Efficacy and safety of R-TPR-024 / LucentisÂ® in patients with neovascular (wet) age-related macular degeneration

Prospective, multi-center, randomized, double-blind, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-024 / LucentisÂ® in patients with neovascular (wet) age-related macular degeneration

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/014065

Enrollment

159

Registered

2018-05-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: R-TPR-024: Ranibizumab 0.5 mg intravitreal injection every 4 weeks for 24 weeks Control Intervention1: LucentisÂ®: Ranibizumab 0.5 mg intravitreal injection every 4 weeks for 24 weeks

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
immunogenicity, safety and tolerability of R-TPR-024 / LucentisÂ®Timepoint: at week 24 from Baseline	—

Countries

India

Contacts

Public ContactRavikiran Payghan

Reliance Life Sciences Pvt. Ltd.

jamila.joseph@ril.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026