A Phase 1/2 Study of the Safety and Efficacy of BRX011 Oral Administration Once Daily in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Conditions

• Geographic Atrophy

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BRX011 — DRUG
  Subjects will ingest BRX011 orally, as capsules.
• Placebo — DRUG
  Subjects will ingest Placebo orally, as capsules.

Study Details

This study aims to evaluate the safety and efficacy of BRX011, an oral medication, taken once daily by participants with geographic atrophy secondary to age-related macular degeneration. The study is conducted in phases 1 and 2, focusing on assessing both safety (tolerability) and effectiveness (efficacy) of the treatment. Participants: Adults with geographic atrophy due to age-related macular degeneration. Treatment: BRX011 or Placebo is taken once daily as per the protocol. Duration: The study involves multiple visits over 96 weeks to monitor participants' health and response to treatment. Safety Monitoring: Regular checks for adverse events and health status to ensure participant well-being. Checks will include examination of vital signs, clinical labs, ocular exams, and ocular imaging. Primary Outcome Measure: Efficacy of BRX011 in the annual rate of change in the square root of GA area, as specified in the protocol.

Key Dates

First listed

Jun 19, 2025

Start date

Sep 29, 2026

Status verified

Sep 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

152 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: BRX011
• Placebo Comparator: Safflower Oil

Primary Outcome Measure

Annual rate of change in the square root of GA area [ Time Frame: Baseline (Day 0) to Week 96 ]

Central Contacts

• Joseph Trinh
  714-548-1784
  [email protected]

Locations (11)

Find similar trials in Gilbert, AZ

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