To study the safety and efficacy of Ranibizumab of Intas Pharmaceuticals Ltd. in patients with visual impairment.
- Conditions
- Health Condition 1: H353- Degeneration of macula and posterior pole
- Registration Number
- CTRI/2016/03/006739
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 126
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Incidence of adverse events (AEs) and serious adverse events (SAEs <br/ ><br>including any hypersensitivity reactions and significant laboratory <br/ ><br>abnormalities <br/ ><br>â?¢Percentage of patients developing anti-Ranibizumab antibody after 6 <br/ ><br>months of treatment. <br/ ><br>Timepoint: Baseline to week 24
- Secondary Outcome Measures
Name Time Method To assess efficacy of investigational medicinal product in adult patients with wet-AMD.Timepoint: At the end of study (week 24)