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

Phase 3

Completed

• Conditions: neovascular (Wet) age related macular degeneration

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

Brief Summary

This prospective, multi-centre, double-blind, two-arm, parallel group, activecontrol, randomized comparative clinical trial is being conducted to compare the efficacy and safety of R-TPR-024 vs. Lucentis® in patients with neovascular(wet) age-related macular degeneration (AMD).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-07
• Study Completion: 2019-11-18
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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 acuity	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®	at week 24 from Baseline

Trial Locations

Locations (16)

Acharya Vinoba Bhave Rural Hospital; 🇮🇳 Wardha, MAHARASHTRA, India

Dr. B R Ambedkar Medical College; 🇮🇳 Bangalore, KARNATAKA, India

Dr. D Y Patil Medical College, Hospital and Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

GSVM Medical College and Hospital, Kanpur; 🇮🇳 Nagar, UTTAR PRADESH, India

JPM Rotary Club Of Cuttack Eye Hospital and Research Institute; 🇮🇳 Cuttack, ORISSA, India

K R Hospital; 🇮🇳 Mysore, KARNATAKA, India

KIMS Hospital and Research Center; 🇮🇳 Bangalore, KARNATAKA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

King George Medical University,Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

KLEs Dr. Prabhakar Kore Hospital and MRC, Belgaum; 🇮🇳 Belgaum, KARNATAKA, India

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Acharya Vinoba Bhave Rural Hospital

🇮🇳Wardha, MAHARASHTRA, India

Dr Sachin Daigavane

Principal investigator

9372910079

drsachin391977@gmail.com