INTRODUCTION: Late capsular bag distension syndrome (CBS) is a rare complication of the ^lcataract surgery. AIM: The aim is to present 9 cases with delayed presentation and describe their successful management with surgical approach. METHOD: A two-year retrospective review of 9 cases was undertaken. Anterior segment optical coherence tomography (AS-OCT) was used to confirm this diagnosis. Aspiration of the milky fluid with 26 gauge needle followed by capsular bag lavage was performed and aspirated fluid was examined. RESULTS: Patients showed signs of late CBS 6,56 ± 1,94 years after uncomplicated phacoemulsification with intraocular lens (IOL) implantation into the capsular bag. All 9 patients presented with a turbid fluid collection within the distended capsular bag. AS-OCT showed a hyper-reflective material in the space between the IOL and distended posterior capsule. CONCLUSION: Awareness of the manifestations of CBS and choice of the correct imaging modality may lead to regular diagnosis and successful treatment. Management with aspiration of the milky fluid and lavage of the capsular bag is technically safe and effective procedure. It has the advantage of microbial testing of the fluid. AS-OCT is useful tool to differentiate this condition clearly from IOL opacification and posterior capsule opacification.
- MeSH
- Phacoemulsification * MeSH
- Lens Implantation, Intraocular * MeSH
- Middle Aged MeSH
- Humans MeSH
- Lens Diseases diagnosis etiology surgery MeSH
- Tomography, Optical Coherence * MeSH
- Postoperative Complications * MeSH
- Lens Capsule, Crystalline * surgery diagnostic imaging MeSH
- Retrospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Syndrome MeSH
- Visual Acuity physiology MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD). DESIGN: This was a multicenter, double-masked, randomized, controlled phase III trial. PARTICIPANTS: Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab. METHODS: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks. MAIN OUTCOME MEASURES: The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49. RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, -2.23 to 0.13) and 95% CI (-2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups. CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
- MeSH
- Biosimilar Pharmaceuticals * administration & dosage adverse effects MeSH
- Double-Blind Method MeSH
- Angiogenesis Inhibitors administration & dosage adverse effects MeSH
- Intravitreal Injections MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Tomography, Optical Coherence MeSH
- Ranibizumab * administration & dosage adverse effects MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Vascular Endothelial Growth Factor A antagonists & inhibitors MeSH
- Wet Macular Degeneration * drug therapy diagnosis MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Visual Acuity * MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
Cílem práce je na ojedinělém případu pacienta po nadstandardní operaci šedého zákalu s preventivní primární zadní cirkulární kasulorexi (PCCC, z angl. posterior continuous curvilinear capsulorhexis) prezentovat možný vznik proliferativní sekundární katarakty. Vzhledem k negativnímu vlivu na zrakové funkce bylo rozhodnuto o ošetření Nd:YAG laserem, které bylo úspěšné s použitím minimální energie ale s porušením přední hyaloidní membrány. Kazuistika 65letý muž podstoupil na našem pracovišti v roce 2020 nekomplikovanou operaci šedého zákalu obou očí, oboustranně s primární PCCC s implantací tenzního kroužku a umělé nitrooční čočky do pouzdra. V únoru 2023 byl na doporučení spádového očního lékaře vyšetřen na naší ambulanci pro snížení zrakové ostrosti vpravo. Dominantní bylo rozmazané vidění. Diagnóza proliferativní formy sekundární katarakty byla potvrzena a zdokumentována pomocí fotografie předního segmentu v retroiluminaci a předněsegmentového OCT (Optovue, Avanti RTVue XR). Pacient byl indikován k Nd:YAG laserové disrupci proliferací v prostoru PCCC na pravém oku. Návrat zrakové ostrosti k původnímu stavu byl potvrzením správné diagnózy. V literárním přehledu a v diskuzi je shrnuta aktuální problematika sekundární katarakty a použití primární PCCC. Závěr: Sekundární katarakta je hlavní dlouhodobou komplikací moderní chirurgie katarakty. Jednou z možných řešení je preventivní provedení jednoduché PCCC, která může být provázená ojedinělým selháním.
The aim of the study is to present the possible development of proliferative secondary cataracts in the unique case of a patient having undergone premium cataract surgery with preventive primary posterior continuous curvilinear capsulorhexis (PCCC). Due to the negative effect on visual functions, it was decided to treat the patient with an Nd:YAG laser, which was successful with minimal energy but resulted in damage to the anterior hyaloid membrane. Case report In 2020, a 65-year-old man underwent uncomplicated cataract surgery in both eyes at our clinic bilaterally with primary PCCC with implantation of a tension ring and an artificial intraocular lens into the capsule. In February 2023, on the recommendation of the area ophthalmologist, he was examined at our outpatient clinic due to a decrease of visual acuity in the right eye. Blurred vision predominated. A diagnosis of proliferative form of secondary cataract was confirmed and documented using a photo of the anterior segment in retroillumination and anterior segment OCT (Optovue, Avanti RTVue XR). The patient was indicated for Nd:YAG laser disruption by proliferation in the PCCC space in the right eye. The return of visual acuity to its original state confirmed the correct diagnosis. The literature review and discussion summarize the current issue of secondary cataracts and the use of primary PCCC. Conclusion: Secondary cataract is the main long-term complication of modern cataract surgery. One of the possible solutions is the preventive implementation of a simple PCCC, which may be accompanied by isolated failure.
- MeSH
- Capsulorhexis * methods adverse effects MeSH
- Cataract Extraction methods adverse effects MeSH
- Lens Implantation, Intraocular MeSH
- Cataract etiology MeSH
- Lasers, Solid-State therapeutic use MeSH
- Humans MeSH
- Aged MeSH
- Capsule Opacification diagnosis etiology MeSH
- Visual Acuity MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Publication type
- Case Reports MeSH
Cíl: Odchlípení sítnice je náhlý zrak ohrožující stav neprodleně vyžadující chirurgickou intervenci. Cílem této práce je porovnat výsledky pars plana vitrektomie (PPV) u nekomplikovaného rhegmatogenního odchlípení sítnice (RRD) mezi různými typy použitých plynů, polohou a počtem trhlin. Materiál a metodika: Jedná se o retrospektivní nerandomizovanou srovnávací studii pacientů s nekomplikovaným RRD léčených na Oftalmologické klinice od března 2018 do dubna 2021 pomocí PPV. Do studie bylo zařazeno 494 hodnocených očí. Sledována byla anatomická úspěšnost operace s ohledem na rozsah odchlípení sítnice, počtu a polohy trhlin a použité tamponády. Výsledky: Úspěšnost přiložení sítnice jednou operací byla v 90,7 % (448 očí) a konečná anatomická úspěšnost byla ve 100 %. Byl zjištěn velmi slabý párový vztah mezi úspěšností operace u trhlin v oblasti 4–8 hodin a 9–3 hodin (89,1 %, resp. 92 %). Stejně tak nebyly pozorovány žádné významné rozdíly mezi zákroky s použitím plynů SF6 a C3F8 u RRD s trhlinou sítnice mezi 4–8 hodinami (úspěšnost 93,4 % u SF6, resp. 89,1 % u C3F8). Průměrné pooperační zlepšení nejlepší korigované zrakové ostrosti bylo 29,6 písmen ETDRS optotypů a zisk 15 písmen byl zaznamenán u 55,1 % (272 očí). Celkově byla míra komplikací velmi nízká. Závěr: PPV je bezpečná a efektivní metoda řešení RRD. Rozsáhlé zkušenosti s touto metodou nám dovolují u vybraných pacientů používat i krátkodobě působící tamponádu.
Aim: Retinal detachment is an acute sight-threatening condition that requires immediate surgical intervention. The aim of this study is to compare the outcomes of pars plana vitrectomy (PPV) for uncomplicated rhegmatogenous retinal detachment (RRD) between the different types of gases used, the position, and the number of tears. Material and Methods: This is a retrospective non-randomized comparative study of patients with uncomplicated RRD treated at the Department of Ophthalmology from March 2018 to April 2021 using PPV. A total of 494 evaluated eyes were included in the study. The anatomical success of the surgery was monitored with regard to the extent of retinal detachment, the number and position of tears, and the tamponade used. Results: The success rate of retinal reattachment with a single operation was 90.7% (448 eyes), and the final anatomical success rate was 100%. A very weak paired relationship was found between the success of the surgery for tears in the 4–8 hours region and the 9–3 hours region (89.1% vs. 92%). Similarly, no significant differences were observed between procedures using SF6 and C3F8 gases for RRD with a tear in the 4–8 hours region (success rate 93.4% for SF6 vs. 89.1% for C3F8). The average postoperative improvement of best corrected visual acuity was 29.6 ETDRS letters, and a gain of 15 letters was recorded in 55.1% (272 eyes). Overall, the complication rate was very low. Conclusion: PPV is a safe and effective method for treating RRD. Extensive experience with this method allows the use of short-acting tamponades in selected patients.
Cíl: Retrospektivně zhodnotit anatomickou a funkční úspěšnost chirurgického řešení rhegmatogenního odchlípení sítnice (ROS) na jediném, posledním vidoucím oku. Materiál a metody: Soubor tvoří 28 očí 28 pacientů, z toho 19 (68 %) mužů, průměrného věku 46 let operovaných jedním chirurgem pro ROS na Oční klinice FN a LF MU Brno od 1. 7. 2019 do 30. 4. 2023 kryochirurgickou technikou anebo 25G+ PPV. U 11 pacientů byla provedena 25G+ PPV s našitím preekvatoriální cerkláže. V anamnéze pacientů bylo přípustné tupé poranění oka a nekomplikovaná operace šedého zákalu s implantací zadněkomorové nitrooční čočky. Příčinou ROS byla/y retinální trhlina/y bez ohledu na jejich počet a lokalizaci. Transparentnost předního segmentu oka umožňovala spolehlivou vizualizaci zadního segmentu. Přípustná byla předoperační proliferativní vitreoretinopatie (PVR) stupně A-D2. Vyloučeni byli pacienti, s pronikajícím očním poraněním v anamnéze. Pacienti byli hodnoceni 1–3 měsíce po PPV. Operace byla anatomicky úspěšná, pokud byla sítnice přiložená v plném rozsahu. U každého pacienta byla hodnocena výsledná zraková ostrost (ZO) na Snellenově optotypu. Pro číselné vyjádření výsledků byl použit aritmetický průměr a numerické hodnoty byly rovněž vyjádřeny v procentech. Poněvadž nebyly vzájemně porovnávány různé skupiny, nebylo potřeba použít žádný statistický test. Výsledky: U 27 pacientů (97 %) jsme dosáhli přiložení sítnice v celém rozsahu, u 1 (3 %) pacienta zůstala sítnice odchlípená a konstatovali jsme anatomický neúspěch léčby. 9 (32%) pacientů dosáhlo ZO ≥ 4/8. Závěr: Kryochirurgickou techniku s využitím episklerálně fixovaných cerklážních pásků a plomb, 25G+ PPV a případně i jejich vzájemnou kombinaci považujeme za vhodné způsoby řešení ROS na jediném, posledním vidoucím oku.
Aim: To retrospectively evaluate the anatomical and functional success of surgical treatment of rhegmatogenous retinal detachment (RRD) in the only remaining seeing eye. Material and methods: The study included 28 eyes of 28 patients, 19 (68%) of whom were men, with an average age of 46 years. They were operated on by a single surgeon for RRD at the Eye Clinic of the University Hospital and Faculty of Medicine, Masaryk University in Brno, from July 1, 2019, to April 30, 2023, using cryosurgical techniques and/or 25G+ pars plana vitrectomy (PPV). In 11 patients, 25G+ PPV was performed with the application of a pre-equatorial cerclage. The Blunt ocular trauma and uncomplicated cataract surgery with implantation of a posterior chamber intraocular lens were admissible within the patient histories. The cause of RRD was retinal tear(s) regardless of their number and location. The transparency of the anterior segment of the eye enabled reliable visualization of the posterior segment. Preoperative proliferative vitreoretinopathy (PVR) grades A-D2 were acceptable. Patients with a history of penetrating eye injury were excluded. Patients were evaluated 1-3 months after the performance of PPV. The surgery was considered anatomically successful if the retina was completely reattached. Each patient's final visual acuity (VA) was assessed using a Snellen chart. Numerical results were expressed as arithmetic means and percentages. Since the different groups were not compared, no statistical tests were needed. Results: Retinal reattachment was achieved in 27 patients (97%), while 1 patient (3%) experienced retinal detachment, resulting in anatomical failure of the treatment. 9 patients (32%) achieved VA ≥ 4/8. Conclusion: We consider cryosurgical techniques using episclerally fixed cerclage bands and buckles, 25G+ PPV, and possibly a combination thereof, to be suitable methods for treating RRD in the only remaining seeing eye.
- MeSH
- Astigmatism MeSH
- Contraindications, Procedure MeSH
- Middle Aged MeSH
- Humans MeSH
- Multifocal Intraocular Lenses * MeSH
- Refractive Errors therapy MeSH
- Aged MeSH
- Anxiety complications MeSH
- Visual Acuity MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Case Reports MeSH
Age-related macular degeneration (AMD) is a progressive chronic disease causing visual impairment or central vision loss in the elderly. We hypothesized that successful rheopheresis would be associated with positive changes in soluble endoglin (sENG), PSCK9, alpha-2-macroglobulin (A2M), and hs-CRP levels. 31 elderly patients with the dry form of AMD, treated with rheopheresis with a follow-up period of at least 5 years and an average age of 68 ± 4 years, were evaluated. Each treated patient received a series of 8 procedures in 10 weeks and, after the 2-year period, another 2 procedures within 1 week. Then, the patients were followed up every 6 months and divided into the successfully treated and therapeutic failure group according to best-corrected visual acuity (BCVA), size of the drusen area, and the drusenoid pigment epithelium detachment (DPED). Based on the ophthalmological assessment, rheopheresis treatment was successful in 73% of AMD patients. The therapy was associated with a significant decrease in total cholesterol, LDL-C, HDL-C, apoprotein B, lipoprotein (a) levels, and rheologically important parameters, irrespective of the therapy's success or failure. The success of rheopheresis therapy was exclusively related to a significant decrease in sENG and A2M levels. Over the long term, rheopheresis prevented the decline of BCVA, reduced the DPED and area of macular drusen, and improved the preservation of an intact photoreceptor ellipsoid zone in most patients. Moreover, we showed for the first time that sENG and A2M could be potentially sensitive biomarkers of successful rheopheresis procedure, irrespective of lipid parameters changes.
- MeSH
- Biomarkers * blood MeSH
- Endoglin * blood MeSH
- Middle Aged MeSH
- Humans MeSH
- Macular Degeneration * therapy blood MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Visual Acuity MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
Cíl: Porovnat funkční a anatomické výsledky mezi technikou invertovaného laloku a konvenčním odstraněním interní limitující membrány (ILM) při operačním řešení idiopatických makulárních děr (IMD). Metodika: Retrospektivně jsme hodnotili anatomické a funkční výsledky u 67 očí 65 pacientů operovaných pro IMD. Pacienti byli operováni buď technikou konvenčního peelingu ILM (první skupina), nebo technikou invertovaného laloku ILM (druhá skupina). Do první skupiny bylo zařazeno 43 očí 41 pacientů, do druhé skupiny 24 očí 24 pacientů. K operaci jsme indikovali pouze pacienty s IMD stádia 2–4 dle Gasseho klasifikace. Před a dva měsíce po operaci byla vždy stanovená nejlépe korigovaná zraková ostrost (ZO). Dále bylo provedené srovnání obou technik podle průměrného zisku písmen po operaci a efekt operace byl zhodnocen pomocí OCT, zda došlo k uzavření IMD. U obou technik byla provedena 25G PPV s tamponádou SF6. Výsledky: U konvenčního odstranění ILM došlo k uzavření díry u 41 očí. U jednoho oka nedošlo k uzavření díry ani po reoperaci stejnou technikou. Medián zisku písmen ETDRS byl 7,0. ZO zůstala stejná u 2 očí (4,7 %), v 7 případech (16,2 %) se ZO zhoršila a ve všech ostatních případech došlo k jejímu zlepšení (79,0 %). U 16 očí (37,2 %) se ZO zlepšila o 2 a více řádků ETDRS optotypů. U invertovaného flapu došlo k uzavření díry u všech 24 sledovaných očí. Medián zisku písmen ETDRS byl 9,5. ZO zůstala stejná u 2 očí (8,3 %), ve 2 případech (8,3 %) se ZO zhoršila a ve všech ostatních případech došlo k jejímu zlepšení (83,3 %). U 12 očí (50,0 %) se ZO zlepšila o 2 a více řádků ETDRS optotypů. Peroperačně a pooperačně nebyly žádné závažné komplikace. Závěr: Naše studie prokázala bezpečnost a účinnost obou metod. Přestože výsledky nebyly statisticky signifikantní, technika invertovaného laloku měla oproti konvenční technice peelingu ILM v našem souboru očí větší zisk písmen ETDRS (9,5 vs. 7,0) a počet uzavřených děr (100 % vs. 95,3 %).
Aim: To compare functional and anatomical outcomes between the inverted flap technique and conventional removal of the internal limiting membrane (ILM) in the surgical management of idiopathic macular hole (IMH). Material and methods: We retrospectively evaluated the anatomical and functional results in 67 eyes of 65 patients operated on for IMH. The patients were operated on either using the conventional ILM peeling technique (first group) or with the inverted ILM flap technique (second group). 43 eyes of 41 patients were included in the first group, 24 eyes of 24 patients in the second group. We indicated for surgery only patients with IMH stage 2–4 according to the Gasse classification. Best corrected visual acuity (VA) was always determined before and two months after surgery. Furthermore, a comparison of both techniques was made according to the average letter gain after surgery, and the effect of surgery was evaluated using OCT with regard to whether IMH closure succeeded. For both techniques, 25G PPV with SF6 tamponade was performed. Results: Hole closure took place in 41 eyes with conventional ILM removal. In one eye, the hole did not close even after reoperation with the same technique. Median ETDRS letter gain was 7.0. VA remained the same in 2 eyes (4.7%), worsened in 7 cases (16.2%), and improved in all other cases (79.0%). In 16 eyes (37.2%), VA improved by 2 or more lines of ETDRS charts. Using the inverted flap technique, the hole was closed in all 24 monitored eyes. Median ETDRS letter gain was 9.5. VA remained the same in 2 eyes (8.3%), worsened in 2 cases (8.3%), and improved in all other cases (83.3%). In 12 eyes (50.0%), VA improved by 2 or more lines of ETDRS charts. There were no serious complications intraoperatively or postoperatively. Conclusion: Our study demonstrated the safety and efficacy of both methods. Although the results were not statistically significant, the inverted flap technique recorded a greater ETDRS letter gain (9.5 vs. 7.0) and proportion of closed holes (100% vs. 95.3%) compared to the conventional ILM peeling technique in our set of eyes.
- Keywords
- invertovaný lalok, peeling MLI,
- MeSH
- Humans MeSH
- Ophthalmologic Surgical Procedures * classification methods statistics & numerical data MeSH
- Retinal Perforations * surgery classification therapy MeSH
- Retrospective Studies MeSH
- Trypan Blue therapeutic use MeSH
- Vitrectomy classification methods MeSH
- Endotamponade classification methods MeSH
- Treatment Outcome MeSH
- Visual Acuity MeSH
- Check Tag
- Humans MeSH
PURPOSE: The purpose of this study was to describe 5 cases (10 eyes) that, following purely cosmetic femtosecond laser-assisted keratopigmentation (KTP), showed evolution toward corneal ectasia during a variable postoperative period. METHODS: In a case series, 5 patients after bilateral purely cosmetic KTP showed progressive changes in topographic, refractive, and even in visual performance values manifesting from 6 months to 4 years following the procedure. A femtosecond laser-assisted cosmetic intrastromal KTP technique was performed in all patients using micronized mineral pigments. Two patients underwent a retouch using superficial automated KTP to optimize cosmetic outcome. RESULTS: All patients preoperatively demonstrated normal corneal topography with no intraocular pathology and unimpaired visual acuity. One of the cases developed corneal ectasia after magnetic resonance imaging, another confirmed intensive eye rubbing due to allergic conjunctivitis, and 1 patient underwent previous myopic laser in situ keratomileusis procedure. The rest did not show any preoperative clinical evidence potentially related to the development of the keratectasia. One case rather demonstrated modification of keratometry (K) values than a clear corneal ectasia. Three cases were treated with epi-off corneal cross-linking. CONCLUSIONS: Corneal ectasia is a potential complication after cosmetic KTP and should be included in the preoperative informed consent. A comprehensive preoperative screening is necessary to exclude suspicious cases, and patients should be instructed to avoid eye rubbing and other maneuvers that could affect the potential development of this complication.
- MeSH
- Dilatation, Pathologic etiology MeSH
- Adult MeSH
- Keratoconus * etiology MeSH
- Cosmetic Techniques * adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Corneal Diseases * etiology diagnosis MeSH
- Refraction, Ocular physiology MeSH
- Corneal Topography MeSH
- Corneal Stroma surgery MeSH
- Tattooing * adverse effects MeSH
- Visual Acuity physiology MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Case Reports MeSH
IMPORTANCE: Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME). OBJECTIVE: To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME. DESIGN, SETTING, AND PARTICIPANTS: This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Study data were analyzed from October to December 2021. INTERVENTIONS: Formulations of MYL-1701P (0.5-mg vial) or reference aflibercept every 4 weeks for 5 consecutive intravitreal injections, followed by every 8 weeks through week 52. MAIN OUTCOMES AND MEASURES: The primary outcome was the adjusted difference in least squares mean (SE) change from baseline BCVA letter score at week 8 with an equivalence margin of -3 to +3 letters. Secondary outcomes included change in central subfield thickness (CST), BCVA, number of injections over 52 weeks, incidence of adverse events (AEs), and antidrug antibodies (ADAs). RESULTS: A total of 355 participants (mean [SD] age, 62.2 [9.2] years; 216 male [60.8%]) were randomized to MYL-1701P (179 participants [50.4%]) and aflibercept (176 participants [49.6%]). At week 8, mean (SE) change in BCVA was 6.60 (0.55) letters vs 6.56 (0.55) letters in the MYL-1701P vs aflibercept groups. The adjusted mean difference of 0.04 letters (90% CI, -1.16 to 1.24 letters) met the primary outcome. At week 8, mean (SE) change in CST was -112 (7) μm vs -124 (7) μm in the MYL-1701P vs aflibercept groups (adjusted mean difference, 12 μm; 90% CI, -3 to 26 μm). The incidence of treatment-emergent AEs in the MYL-1701P and aflibercept arms were ocular (30.9% [55 of 178] vs 29.5% [52 of 176]), serious ocular (0.6% [1 of 178] vs 1.1% [2 of 176]), nonocular (65.2% [116 of 178] vs 65.3% [115 of 176]), and serious nonocular (16.9% [30 of 178] vs 11.9% [21 of 176]). The mean (SD) total number of injections was 8.4 (2.1) vs 8.7 (1.8) in the MYL-1701P vs aflibercept groups. The incidence of treatment-induced or treatment-boosted ADAs was 2.8% (5 of 177) vs 5.7% (10 of 176) in the MYL-1701P vs aflibercept arms. CONCLUSIONS AND RELEVANCE: MYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03610646.
- MeSH
- Biosimilar Pharmaceuticals * therapeutic use adverse effects MeSH
- Diabetic Retinopathy * drug therapy diagnosis physiopathology MeSH
- Double-Blind Method MeSH
- Angiogenesis Inhibitors * administration & dosage therapeutic use adverse effects MeSH
- Intravitreal Injections * MeSH
- Middle Aged MeSH
- Humans MeSH
- Macular Edema * drug therapy physiopathology diagnosis MeSH
- Tomography, Optical Coherence MeSH
- Receptors, Vascular Endothelial Growth Factor * administration & dosage MeSH
- Recombinant Fusion Proteins * therapeutic use administration & dosage MeSH
- Aged MeSH
- Vascular Endothelial Growth Factor A antagonists & inhibitors MeSH
- Treatment Outcome MeSH
- Visual Acuity * physiology MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
