(1) ICD-10 Condition: H353||Degeneration of macula and posterior pole,
Intervention / Comparator Agent
Dose: 0.5 mg intravitreal injection, Frequency: every 4 weeks, Mode of Administration: Intravitreal injection, Duration of treatment: 24 weeks
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. (Only one eye will be assessed in the study. If both eyes are eligible, the one with the better visual acuity is selected for treatment and study unless, based on medical reasons, the investigator deemed the other eye the more appropriate candidate for treatment and study).
4. Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
1.Prior treatment with any intravitreal drug, verteporfin or photodynamic therapy in the study eye and/or non study eye within past 3 months before study entry
2.Extrafoveal Laser photocoagulation within 1 month before study entry in the study eye
3.Prior treatment with systemic or intravitreal bevacizumab therapy within last 6 months
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 6 month study period or that could contribute to a loss of best corrected visual acuity over the 6 months study period
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
Method of Generating Random Sequence
Method of Concealment
•Incidence of adverse events (AEs) and serious adverse events (SAEs
including any hypersensitivity reactions and significant laboratory
•Percentage of patients developing anti-Ranibizumab antibody after 6
months of treatment.
Baseline to week 24
To assess efficacy of investigational medicinal product in adult patients with wet-AMD.
At the end of study (week 24)
Target Sample Size
Total Sample Size="126" Sample Size from India="126" Final Enrollment numbers achieved (Total)= "126" Final Enrollment numbers achieved (India)="126"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Age-related macular degeneration (AMD) is one of the leading causes of
substantial and irreversible vision loss. Without treatment, the neovascular form of AMD
leads to severe quality-of-life loss within a short time period and
considerable economic burden. The Food and Drug
Administration (FDA) approved ranibizumab for treatment of subfoveal
neovascular AMD in June, 2006. It was the first treatment for AMD shown to
improve visual acuity in a substantial percentage of patients. Intas’
formulation of Ranibizumab has been approved by the Indian drug authority for
sale in Indian market. Marketing authorisation in India was obtained following
submission of the results of a comparative efficacy and safety study with
Novartis’ Reference product in 104 adult patients of wet AMD receiving 0.5 mg
intravitreally every 4 weeks for 12 weeks duration. The proposed study is being
undertaken to generate additional safety, immunogenicity and efficacy data of
Intas ranibizumab for the treatment of wet AMD in adult patients aged ≥50