Health Condition 1: null- Wet AMD (Age related Macular Degeneration)
Conditions
Interventions
Intervention1: Ranibizumab: 0.5 mg intravitreal injection once every 4 weeks for 3 month
Control Intervention1: Lucentis: 0.5 mg intravitreal injection once every 4 weeks for 3 month
Sponsors
Intas Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participant with age >= 50 years at the time of screening 2. Active primary or recurrent subfoveal lesion with CNV(choroidal neovascularization) secondary to AMD, involving the foveal center 3. Have a best corrected visual acuity of 20/40 to 20/320 using Early Treatment Diabetic Retinopathy Study chart- ETDRS (Snellen equivalent) in the study eye. 4. Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any intravitreal drug, verteporfin or photodynamic therapy in the study eye in the past (except for extrafoveal laser photocoagulation in the study eye) and/or non study eye within past 3 months before study entry 2. Laser photocoagulation within 1 month before study entry in the study eye 3. Prior treatment with systemic or intravitreal bevacizumab therapy 4. Subfoveal fibrosis or atrophy in the study eye 5. CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia etc 6. Retinal pigment epithelial tear involving the macula in the study eye 7. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 3 month study period or that could contribute to a loss of best corrected visual acuity over the 3 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma, uveitis, previous corneal transplant, recent cataract surgery etc). The decision regarding exclusion is to be based on the opinion of the investigator. 8. Active intraocular inflammation or ongoing infection in the study eye 9. Vitreous hemorrhage in the study eye or history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye 10. Any other retinal pathology i.e. CRVO, CRAO etc. 11. Known hypersensitivity to ranibizumab or any of the components of study medication 12. Previous participation in any clinical trial within 1 month before the entry of the study 13. Any other condition that in the opinion of investigator could hamper participation in the study 14. Suspected or confirmed poor compliance, according to investigators judgment, in completing the trial and follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who loose fewer than 15 letters (approximately 3 lines) from baseline visual acuityTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of drug related Adverse Events as assessed by clinical and ophthalmic examination, vitals and / or laboratory parameters in both the treatment armsTimepoint: 3 months;Mean increase in best corrected visual acuity (BCVA) from baseline in of the study eye at end study visitTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Naman Shah
Intas Biopharmaceuticals Limited
Outcome results
None listed