OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)

Conditions

• Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 2.0 mg OPT-302 — BIOLOGICAL
  intravitreal injection
• 0.5 mg ranibizumab — BIOLOGICAL
  intravitreal injection
• Sham — PROCEDURE
  intravitreal injection

Study Details

A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Key Dates

First listed

Feb 17, 2021

Start date

Mar 12, 2021

Status verified

Jun 2025

Primary completion

Mar 31, 2025

Completion

Mar 31, 2025

Study Design

Enrollment

986 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302
  0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
• Experimental: 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302
  0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
• Sham Comparator: 0.5 mg ranibizumab with sham
  0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.

Primary Outcome Measure

Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters [ Time Frame: Baseline to Week 52 ]

Locations (76)

Find similar trials in Phoenix, AZ

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