Efficacy and safety ofR-TPR-024 / Lucentis® in patients with neovascular (wet) age-related macular degeneratio

Phase 3

Completed

• Conditions: Health Condition 1: null- neovascular (Wet) age related macular degeneration

• Registration Number: CTRI/2018/05/014065
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 159

Inclusion Criteria

1.Male or female patients of age >= 50 years.

2.Active primary or recurrent subfoveal lesions with classic or occult 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.

Exclusion Criteria

1.Treatment with verteporfin photodynamic therapy in the study eye within 6 months or in the nonstudy eye within 1 week prior to randomization.

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 randomization.

4.CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.

5.Patients with controlled or uncontrolled diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of patients who lost fewer than 15 letters in visual acuityTimepoint: proportion of patients who lost fewer than 15 letters in visual acuity

Secondary Outcome Measures

Name	Time	Method
immunogenicity, safety and tolerability of R-TPR-024 / Lucentis®Timepoint: at week 24 from Baseline