The purpose of this research study is to evaluate safety and efficacy of RanizuRelTM containing Ranibizumab for intra-vitreal injection, manufactured by Reliance Life Sciences, Pvt. Ltd. India in patients with neovascular (wet) age-related macular degeneration.
- Conditions
- Health Condition 1: H353- Degeneration of macula and posterior pole
- Registration Number
- CTRI/2021/06/033972
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
1. Male or female patients of age = 50 years.
2. Active primary or recurrent subfoveal lesions with choroidal neovascularization (CNV)
secondary to age-related macular degeneration (AMD) in the study eye.
3. Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study
(ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye.
4. Able to understand the study procedures and the risks involved, willing to provide
written Informed Consent, and able to adhere to study schedules and requirements.
5. Men and women of childbearing potential must be using adequate birth control
measures, as discussed with the study doctor. Menopausal females must have
experienced their last period more than 12 months prior to study entry to be classified
as not of childbearing potential.
1. Treatment with verteporfin photodynamic therapy in the study eye within 6 months or
in the nonstudy eye within 1 week prior to enrolment.
2. Previous external-beam radiation therapy, transpupillary thermotherapy or subfoveal
focal laser photocoagulation in the study eye.
3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month
prior to enrolment.
4. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
pathologic myopia.
5. History of submacular surgery or other surgical intervention for AMD, previous
intravitreal drug delivery or vitrectomy surgery in the study eye.
6. Current vitreous haemorrhage, subretinal hemorrhage that involves the fovea,
subfoveal fibrosis or atrophy, active intraocular inflammation or infection in the study
eye
7. History of retinal pigment epithelial tear, rhegmatogenous retinal detachment or
macular hole (Stage 3 or 4), aphakia or absence of the posterior capsule in the study
eye.
8. Uncontrolled glaucoma (defined as intraocular pressure of 30 mmHg or more despite
treatment with antiglaucoma medications) or history of glaucoma filtering surgery in
the study eye
9. Intraocular surgery (including cataract surgery) within 2 months in the study eye prior
to enrolment.
10. Any concurrent intraocular condition in the study eye that, in the opinion of the
investigator, could either require medical or surgical intervention during the study
period, or could likely contribute to loss of at least 2 Snellen equivalent lines of best
corrected visual acuity.
11. History of idiopathic or autoimmune-associated uveitis in either eye.
12. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
13. Patients with history of diabetes mellitus.with HbA1c >8% [64 mmol/mol]
14. Patients who are HIV, HBsAg, HCV test positive.
15. Patients with positive urine pregnancy test at screening.
16. Hypersensitivity to ranibizumab or any of the excipients, or history of allergy to
fluorescein.
17. Participation in any clinical study of an investigational product within previous 3
months.
18. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral
disease that renders the patient incapable of participating in the study.
19. History of other disease, active systemic infection, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug or that
might affect interpretation of the results of the study or render the subject at high risk
for treatment complications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events occurring during the study,Timepoint: at Day 0 , Week 4, Week 8 , Week 12, Week 16, Week 20 , Week 24 and Withdrawal Visit.
- Secondary Outcome Measures
Name Time Method