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NCT07029945
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
Phase 1, PHASE2 trial testing BRX011 in Geographic Atrophy in 152 participants. Not yet recruiting.
11 November 2026
Quick facts
| Lead sponsor | Biojiva LLC |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 152 |
| Start date | 7 July 2025 |
| Primary completion | 11 November 2026 |
| Estimated completion | 11 February 2027 |
Drugs / interventions tested
- BRX011 — full drug profile →
- Placebo
Conditions studied
- Geographic Atrophy — all drugs for Geographic Atrophy →
Sponsor
Biojiva LLC — full company profile →
Who can join
55 and older, any sex, with Geographic Atrophy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Oral Deuterated Docosahexaenoic Acid Protects Against Onset and Progression of RPE Degeneration in a Mouse Model of Chronic Oxidative Stress.
Foshe S, Anderson BD, Song Y, Shi S, et al · · 2026 · PMID 41979253 · DOI 10.1167/iovs.67.4.28
Verify or expand the search:
- PubMed search for NCT07029945
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Geographic Atrophy
Currently open trials in the same condition.
- NCT07215234 — A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Se · Phase 1, PHASE2 · recruiting
- NCT06961370 — A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO76693 · Phase 1 · recruiting
- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06769048 — A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) C · Phase 2 · active not recruiting
- NCT06805474 — A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT · recruiting
Other Biojiva LLC trials
Trials by the same sponsor.
- NCT04937530 — RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY · Phase 2 · unknown
- NCT04762589 — RT001 in Amyotrophic Lateral Sclerosis · Phase 2 · completed
- NCT04102501 — A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia · Phase 3 · completed
- NCT04027816 — A Natural History Study of Infantile Neuroaxonal Dystrophy · completed
- NCT03570931 — A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy · Phase 2, PHASE3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07029945 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biojiva LLC
- Last refreshed: 26 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07029945.
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