A 73-year-old woman presented with a best-corrected visual acuity of 6/9 in her right eye and 6/36 in her left eye. Fundus examination revealed signs of age related macular degeneration in both eyes. In her right eye it was just dry form of the disease, in left one an elevated lesion associated with retinal cystoid edema was detected. Ocular coherence tomography and fluorescein angiogram confirmed a subfoveal occult choroidal neovascular membrane. We decided for intravitreal ranibizumab (Lucentis, 0.5 mg) treatment. One month after first injection, best-corrected visual acuity improved to 6/15 in her left eye. After six months, best-corrected visual acuity further improved to 6/12, with complete resolution subretinal fluid on ocular coherence tomography.

• MeSH
• humanizované monoklonální protilátky MeSH
• injekce intravitreální MeSH
• lidé MeSH
• monoklonální protilátky aplikace a dávkování   MeSH
• neovaskularizace choroidey diagnóza   farmakoterapie   MeSH
• ranibizumab MeSH
• senioři MeSH
• Check Tag
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• anglický abstrakt MeSH
• časopisecké články MeSH
• kazuistiky MeSH
• Názvy látek
• humanizované monoklonální protilátky MeSH
• monoklonální protilátky MeSH
• ranibizumab MeSH

AIM: The aim of this study was the retrospective follow up of Age-Related Macular Degeneration (ARMD) wet form patients treated with ranibizumab during 24 months period. The data were recorded into the AMADEuS (Age-related MAcular DEgeneration in patientS in the Czech Republic) Registry and after their evaluation compared with treatment results obtained from other departments of ophthalmology collaborating in the AMADEuS project or results of some foreign studies as well. PATIENTS AND METHODS: The group consisted of patients registered since October 1, 2008 until June 11, 2012, followed up for 24 months period. There were 90 eyes of 89 patients. All patients were completely examined in the Macular ambulance of the Department of Ophthalmology in the Faculty Hospital Brno-Bohunice, Czech Republic, E.U., and consequently the ranibizumab (Lucentis, Novartis) was applied intravitreally in three initials doses one month apart. Thereafter, ranibizumab was applied "on demand". In 43.3 % of eyes the mostly classical, in 27.8 % of eyes occult, and in 28.9 % of eyes the minimally classical choroid neovascular membrane was present. The initial visual acuity was in 3.3 % of eyes in the range 15 - 30 letters of ETDRS optotypes (20/500 - 20/200), in 61.1 % of eyes in the range 31 - 60 letters (20/200 - 20/63), and the visual acuity better than 61 letters of ETDRS optotypes (better than 20/63) was in 35.6 % of eyes. RESULTS: The average initial best-corrected visual acuity (BCVA) in our group of patients was 54.2 letters of EDTRS (SD ± 14.4). At the visit at three months after the start of the treatment the BCVA was 59.6 letters of EDTRS (SD ± 15.0), at the visit after 6 months 57.3 letters of EDTRS (SD ± 14.7), after one year of the study 54.8 letters of EDTRS (SD ± 16), after 18 months of the study 53.4 letters of EDTRS (SD ± 16,8), and after 24 months of the study was the BCVA 51.7 letters of EDTRS (SD ± 16.9). The average CRT (central retinal thickness) value by means of the OCT (optic coherence tomography) examination was at the beginning of the treatment 311.4 μm (SD ± 117.9), after 3 months of treatment 233.5 μm, (SD ± 85.4), after 6 months of treatment 262.2 μm, (SD ± 102,4), after 12 months 261 μm (SD ± 88,4), after 18 months 254.9 μm (SD ± 70.0), and after 24 months 249 μm (SD ± 87.5). The average number of ranibizumab doses during the follow-up period was 5.6. After the 24 months follow-up period, the gain of 15 or more letters of EDTRS was recorded in 11.1 % of patients, the gain of 1 - 14 letters of EDTRS optotypes was recorded in 32.2 % of patients, the decrease of 14 or less letters of EDTRS optotypes was found in 21.2 % of patients, and the decrease of 15 or more letters was found in our group in 22.2 % of patients. CONCLUSION: The ARMD wet form treatment using ranibizumab is up to date the most effective available therapy. The AMADEuS registry is of great importance in the reviewing of the effectiveness of the ARMD wet form treatment.

• MeSH
• humanizované monoklonální protilátky terapeutické užití   MeSH
• lidé středního věku MeSH
• lidé MeSH
• ranibizumab MeSH
• registrace MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• vlhká makulární degenerace farmakoterapie   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• anglický abstrakt MeSH
• časopisecké články MeSH
• Názvy látek
• humanizované monoklonální protilátky MeSH
• ranibizumab MeSH

OBJECTIVE: To evaluate the anatomical and functional outcome of ranibizumab therapy in patients with idiopathic choroidal neovascularization (CNV). File and Methodology: The group consists of 6 patients. Patients were older 18 years but they were under 50 years of age. The monitoring period lasted 12 months. We confirmed active idiopathic CNV in subfoveal position with fluorescein angiography (FAg) and optical coherence tomography (OCT). The activity of idiopathic CNV we demonstrated with leakage of dye by FAg examination. The presence of serous retinal pigment epithelium detachment and / or subretinal fluid and / or intraretinal edema in the form of intraretinal cysts demonstrated activity of CNV on OCT scans. A decrease of the visual acuity under 85 letters was observed at the ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity chart. After the initial administration of ranibizumab a pro re nata regimen was used. We indicated repeated injection of ranibizumab in patients with signs of activity of idiopathic CNV on OCT scans or by FAg. Also we indicated repeated injection of ranibizumab in patients with new loss of visual acuity on the ETDRS visual acuity chart connected with signs of activity of CNV on OCT scans or by FAg. RESULTS: On average, we observed the gain of +11 letters on the ETDRS visual acuity chart after 12 months of the follow-up period. On average we observed reduction of central macular thickness -233μm. At the 12th month of follow-up we observed in all patients of our group only inactive scar without exudation. No serous retinal pigment eithelium detachment, subretinal fluid or intraretinal cysts were observed. Only 3 injections of ranibizumab were administered on average to each patient during the 12 months of the follow-up period. CONCLUSION: In our study, we observed the positive effect of ranibizumab on the course of idiopathic CNV. With ranibizumab treatment we achieved regression of CNV with resorption of macular edema in all patients of our group. With the disappearance of the activity of idiopathic CNV ranibizumab gives real hope to improve visual acuity.

• Klíčová slova
• anti-VEGF treatment, idiopathic choroidal neovascular membrane, ranibizumab,
• MeSH
• fluoresceinová angiografie MeSH
• inhibitory angiogeneze * terapeutické užití   MeSH
• injekce intravitreální MeSH
• lidé středního věku MeSH
• lidé MeSH
• neovaskularizace choroidey * farmakoterapie   MeSH
• optická koherentní tomografie MeSH
• ranibizumab * terapeutické užití   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• inhibitory angiogeneze * MeSH
• ranibizumab * MeSH

• MeSH
• humanizované monoklonální protilátky MeSH
• lidé MeSH
• makulární degenerace farmakoterapie   MeSH
• monoklonální protilátky terapeutické užití   MeSH
• ranibizumab MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Názvy látek
• humanizované monoklonální protilátky MeSH
• monoklonální protilátky MeSH
• ranibizumab MeSH

AIM: To present the case of a patient with myopic choroidal neovascular membrane (mCNV) in the 3rd trimester of pregnancy, who was treated with intravitreal ranibizumab. CASE REPORT: The 34-year-old patient was referred to the Department of Ophthalmology of the University Hospital Kralovske Vinohrady in January 2020 for mCNV on her right eye (RE). The patient was in the 34th week of pregnancy. Initial best corrected visual acuity (BCVA) was 68 ETDRS letters. Spherical equivalent of the RE was -11.5 dioptres, axial length of the RE was 27.7 mm. Pigmented CNV with small haemorrhage was present on the retina of the RE. Optical coherence tomography (OCT) of the RE showed a hyperreflective mass above the retinal pigment epithelium, central retinal thickness (CRT) was 310 µm. OCT angiography confirmed the presence of a classic CNV in the macula of the RE. Two weeks later, the hyperreflective lesion and oedema in the macula of the RE increased, the CRT was 329 µm, BCVA remained stable. After discussion with the patient and the treating gynaecologist, intravitreal ranibizumab was administered in the RE in the 36th week of pregnancy. On check-up 3 weeks later, we observed the decrease of macular oedema to 276 µm and the improvement of BCVA to 78 ETDRS letters. The patient delivered a healthy baby girl in the 39th week of pregnancy via caesarean section, postnatal adaptation of the newborn was normal. During further visits, the BCVA improved to 83 ETDRS letters and the macular oedema disappeared completely. 8 months after the first ranibizumab injection, the CNV reactivated, BCVA decreased to 72 ETDRS letters, oedema was present in the macula and the CRT was 309 µm. Another ranibizumab was administered into the RE. The patient then discovered that she was pregnant; according to calculations, she was in the 3rd week of pregnancy at the time of the second ranibizumab injection. After the second injection, BCVA improved to 79 ETDRS letters, macular oedema on the OCT disappeared and CRT decreased to 264 µm. The pregnancy was terminated per patients request. CONCLUSION: Intravitreal administration of ranibizumab in the 3rd trimester of pregnancy led to the improvement of BCVA and decrease of macular oedema in the patient with mCNV. The injection had no adverse effect on the pregnancy or the postnatal adaptation of the newborn. However, it is always necessary to consider the risk/benefit ratio when administering intravitreal antiVEGF drugs in pregnant patients. Thorough discussion with the patient is necessary.

• Klíčová slova
• antiVEGF, myopic choroidal neovascular membrane, pregnancy, ranibizumab,
• MeSH
• císařský řez škodlivé účinky   MeSH
• dospělí MeSH
• humanizované monoklonální protilátky terapeutické užití   MeSH
• inhibitory angiogeneze terapeutické užití   MeSH
• injekce intravitreální MeSH
• lidé MeSH
• makulární edém * etiologie   MeSH
• myopie * komplikace   MeSH
• novorozenec MeSH
• ranibizumab terapeutické užití   MeSH
• těhotenství MeSH
• zraková ostrost MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• novorozenec MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• kazuistiky MeSH
• Názvy látek
• humanizované monoklonální protilátky MeSH
• inhibitory angiogeneze MeSH
• ranibizumab MeSH

PURPOSE: To retrospectively evaluate the efficacy and safety of ranibizumab treatment for macular edema (ME) secondary to branch retina vein occlusion (BRVO) after 24 months. MATERIALS AND METHODS: This study included 39 eyes of 39 patients with ME associated with BRVO treated at the Ophthalmology Department of Faculty Hospital in Hradec Kralove. The average age of included patiens was 69,3 years, the mean duration of symptoms before treament was 5,4 months, the mean baseline visual acuity (VA) was 54,6 ETDRS (Early Treatment Diabetic Retinopathy Study) letters, the mean baseline central retinal thickness (CRT) was 544,9 µm. At 64,1% patients a retinal laserphotocoagulation was performed before intravitreal ranibizumab. After one year, the study was discontinued by 17 patiens, the remaining 22 patients were observed for 24 months. Initially, there were 3 doses of intravitreal ranibizumab administered in monthly intervals, further injections were applied according to PRN (pro re nata) regiment. Patients were examined at baseline and then at 3, 6, 9, 12 and 24 months from initiation of the treatment. In this study, the effect of ranibizumab on functional and morphological parameters of the affected eye was monitored, the safety of this treatment was also evaluated. During the follow-up, a statistically significant improvement in VA was achieved in every visit in comparison to baseline parameters, the mean VA gain at the 3 month visit was 12,1 ETDRS letters (p.

• Klíčová slova
• BRVO, anti-VEGF, branch retinal vein occlusion, ranibizumab,
• MeSH
• inhibitory angiogeneze terapeutické užití   MeSH
• injekce intravitreální MeSH
• lidé MeSH
• makulární edém farmakoterapie   etiologie   MeSH
• okluze retinální žíly komplikace   farmakoterapie   MeSH
• ranibizumab terapeutické užití   MeSH
• retrospektivní studie MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• inhibitory angiogeneze MeSH
• ranibizumab MeSH

The choroidal neovascularization (CNV) is the leading cause of blindness in industrial countries. CNV in age-related macular degeneration (AMRD) is dynamic, multifactor process, which cause wasn't revealed until now. It is obvious that in multifactorial disease no single treatment is optimal, and that the monotherapy can't cover all factors leading to the CVN development. The contemporary modern and variably effective treatment techniques have common characteristic--the treatment is very expensive and it is necessary to repeat it to obtain the treatment effect. The authors refer about 18 months lasting period of follow-up of the group of 25 patients (9 men and 16 women, average age was 68 years, range, 59-76 years of age) who underwent the photodynamic therapy followed by ranibizumab intravitreal injections due to an active CNV. Mostly classical membranes were diagnosed in 18 cases (72%), minimally classical membranes in 5 cases (20%) and occult CNV in 2 patients (8%). The average best corrected visual acuity before the treatment was 46 letters of EDTRS chart, and after the treatment it was 50 letters. From the total number of 25 patients, in 20 (80%) of them the stabilization or improvement (+/- 15 letters of EDTRS chart) was achieved, in two patients the improvement was better than 15 letters (8%). Three patients' visual acuity decreased by more than 15 letters (12%). On average, to stabilize the CNV (after the PDT), 3.16 applications of ranibizumab were needed.

• MeSH
• fotochemoterapie * MeSH
• humanizované monoklonální protilátky MeSH
• injekce intravitreální MeSH
• kombinovaná terapie MeSH
• lidé středního věku MeSH
• lidé MeSH
• makulární degenerace komplikace   farmakoterapie   patofyziologie   MeSH
• monoklonální protilátky aplikace a dávkování   MeSH
• neovaskularizace choroidey komplikace   MeSH
• ranibizumab MeSH
• senioři MeSH
• zraková ostrost MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• anglický abstrakt MeSH
• časopisecké články MeSH
• Názvy látek
• humanizované monoklonální protilátky MeSH
• monoklonální protilátky MeSH
• ranibizumab MeSH

AIM: This study aimed to determine the effects of a single intravitreal ranibizumab injection in rabbits induced with retinoblastoma (RB). MATERIAL AND METHODS: RB was induced in six New Zealand white rabbits by subretinal injection of a cultured WERI-RBb-1 cell line into the right eye. After six weeks, Group A (n = 3) was given intravitreal ranibizumab injection (0.3mg in 0.03ml) and Group B (n = 3) was the control. Baseline and serial clinical examinations were performed on days 1, 3, 6, 12, 15, 18 and 21. The right eyes were enucleated for both groups on day 21 for histopathological examination. RESULTS: The rabbits in both groups developed intraocular lesions which was detectable clinically at one-week post-tumor inoculation. The tumor grew slowly without spontaneous regression. After the animals in Group A were given an intravitreal ranibizumab injection, regression of the tumor was detected clinically, while the tumor in Group B continued to grow slowly. Histopathological findings confirmed the presence of a tumor that closely resembled features of poorly differentiated human RB cells. At the end of 21 days, the size of the tumor was larger in Group B in comparison to Group A. However, the treated group also developed a focal area of retinal hyperplasia. There was no significant side effect of ranibizumab injection except temporary high intraocular pressure immediately post-injection, which was relieved after paracentesis. CONCLUSIONS: Intravitreal ranibizumab is a potential treatment for RB. It is an effective therapy with a tolerable safety profile in this animal experimental study.

• Klíčová slova
• retinoblastoma; intravitreal injection; anti-vascular endothelial growth factor; ranibizumab; animal experimental study,
• MeSH
• inhibitory angiogeneze farmakologie   MeSH
• injekce intravitreální MeSH
• králíci MeSH
• lidé MeSH
• nádory sítnice * chemicky indukované   farmakoterapie   MeSH
• ranibizumab terapeutické užití   MeSH
• retinoblastom * chemicky indukované   farmakoterapie   MeSH
• vaskulární endoteliální růstový faktor A MeSH
• zvířata MeSH
• Check Tag
• králíci MeSH
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• inhibitory angiogeneze MeSH
• ranibizumab MeSH
• vaskulární endoteliální růstový faktor A MeSH

OBJECTIVE: To evaluate the efficacy, safety, and immunogenicity of a ranibizumab biosimilar candidate (XSB-001) versus reference product (Lucentis) for neovascular age-related macular degeneration (nAMD). DESIGN: Phase III, multicenter, randomized, double-masked, parallel-group study. PARTICIPANTS: Patients with nAMD. METHODS: Eligible patients were randomized (1:1) to receive intravitreal injections of XSB-001 or reference ranibizumab (0.5 mg [0.05 ml]) in the study eye once every 4 weeks for 52 weeks. Efficacy and safety assessments continued through 52 weeks of treatment. MAIN OUTCOME MEASURES: Primary end point was change from baseline in best-corrected visual acuity (BCVA) by ETDRS letters at week 8. Biosimilarity was concluded if the 2-sided 90% confidence interval (CI) (United States) or 95% CI (rest of world) for the difference in least-squares (LS) mean change in BCVA at week 8 between treatment groups was within the predefined equivalence margin of ± 3.5 letters. RESULTS: In total, 582 patients (n = 292 XSB-001, n = 290 reference ranibizumab) were randomized. Mean age was 74.1 years, most patients (85.2%) were White, and 55.8% were women. Mean BCVA score at baseline was 61.7 and 61.5 ETDRS letters in the XSB-001 and reference ranibizumab groups, respectively. At week 8, the LS mean (standard error [SE]) change in BCVA from baseline was 4.6 (0.5) ETDRS letters in the XSB-001 group and 6.4 (0.5) letters in the reference ranibizumab group (LS mean [SE] treatment difference: -1.8 [0.7] ETDRS letters; 90% CI, -2.9 to -0.7; 95% CI, -3.1 to -0.5). The 90% CI and 95% CI for LS mean difference in change from baseline were within the predefined equivalence margin. At week 52, LS mean (SE) change in BCVA was 6.4 (0.8) and 7.8 (0.8) letters, respectively (LS mean [SE] treatment difference, -1.5 [1.1] ETDRS letters; 90% CI, -3.3 to 0.4; 95% CI, -3.6 to 0.7). There were no clinically meaningful differences between treatments in anatomical, safety, or immunogenicity end points through week 52. CONCLUSIONS: XSB-001 demonstrated biosimilarity to reference ranibizumab in patients with nAMD. Treatment with XSB-001 for 52 weeks was generally safe and well tolerated, with a safety profile similar to the reference product. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

• Klíčová slova
• Biosimilar, Lucentis, Neovascular age-related macular degeneration, Ranibizumab, XSB-001,
• MeSH
• biosimilární léčivé přípravky * terapeutické užití   MeSH
• inhibitory angiogeneze MeSH
• lidé MeSH
• makulární degenerace * diagnóza   farmakoterapie   chemicky indukované   MeSH
• ranibizumab MeSH
• senioři MeSH
• zraková ostrost MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• biosimilární léčivé přípravky * MeSH
• inhibitory angiogeneze MeSH
• ranibizumab MeSH

The case report presents the difference of the effect of two drugs blocking vascular endothelial growing factor (anti-VEGF)--sodium pegaptanib and ranibizumab--in a female patient with the retinal pigment epithelium (RPE) layer ablation as a part of the exsudative age-related macular degeneration. Fifty-five years old female patient with RPE ablation as a sign of exsudative ARMD and central visual acuity 79 letters of the EDTRS chart in the left eye was treated by 5 intravitreal injections of sodium pegaptanib. The treatment was not sufficiently effective according to the fluorescein angiography (FAG) and optic coherence tomography (OCT) findings and was accompanied by further decrease of the visual acuity to 55 letters of the EDTRS chart. After the medication was switched to ranibizumab with 3 intravitreal applications, the RPE ablation flattened according to the OCT findings and the fluorescein leakage during the FAG markedly decreased. The central visual acuity improved to 63 letters of the EDTRS chart. The decreased activity of the choroidal neovascularization (CNV) is observed during the following 4 months after the last intravitreal application of ranibizumab. Ranibizumab seems to be more effective drug comparing to the sodium pegaptanib in patients with the RPE ablation, but it is necessary to consider the increased probability of the RPE rupture risk.

• MeSH
• aptamery nukleotidové aplikace a dávkování   MeSH
• fluoresceinová angiografie MeSH
• humanizované monoklonální protilátky MeSH
• injekce intravitreální MeSH
• lidé středního věku MeSH
• lidé MeSH
• makulární degenerace farmakoterapie   patologie   patofyziologie   MeSH
• monoklonální protilátky aplikace a dávkování   MeSH
• optická koherentní tomografie MeSH
• ranibizumab MeSH
• retinální pigmentový epitel patologie   MeSH
• zraková ostrost MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• kazuistiky MeSH
• Názvy látek
• aptamery nukleotidové MeSH
• humanizované monoklonální protilátky MeSH
• monoklonální protilátky MeSH
• pegaptanib MeSH Prohlížeč
• ranibizumab MeSH