A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

Conditions

• Exudative Age-related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RBM-007 Injectable Solution — DRUG
  RBM-007 Injectable Solution
• Aflibercept — DRUG
  EYLEA® (aflibercept) Injection, for Intravitreal Use
• Sham — DRUG
  Sham intravitreal injection

Study Details

This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).

Key Dates

Start date

Dec 2, 2019

Status verified

Apr 2023

Primary completion

Nov 19, 2021

Completion

Dec 22, 2021

Study Design

Enrollment

94 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sham + RBM-007
  Sham + RBM-007 intravitreal injection
• Experimental: RBM-007 + Aflibercept
  RBM-007 + Aflibercept intravitreal injection
• Active Comparator: Sham + Aflibercept
  Sham + Aflibercept intravitreal injection

Primary Outcome Measure

Visual Acuity - Continuous [ Time Frame: Week 16 ]

Locations (8)

Find similar trials in Phoenix, AZ