A Phase 1/2 interventional study of BRX011 and Placebo in Geographic Atrophy, sponsored by Biojiva LLC. Recruiting at 17 sites in 2 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Biojiva LLC · Phase 1/2, Interventional, and Treatment
Among 131 studies in Geographic Atrophy with a site in United States — 35 open to participants now, 46 under way, 5 of them phase 3. Geographic Atrophy · United States.
Among the 131 studies in Geographic Atrophy with a site in United States, this one is the 46th largest by planned enrollment of the 107 interventional ones, is one of 9 that started in 2026, is one of 17 in phase 1/2, reaches primary completion later than 34 of the 45 other live ones, and was the 113th registered.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
This study's planned enrollment of 152 is above the median of 70 across 141 interventional studies indexed under Geographic Atrophy.
Browse Geographic Atrophy studies →35 of the 131 studies in Geographic Atrophy with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 40 Geographic Atrophy studies recruiting now, 31 (78%) set no upper age limit and 0 (0%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
The full table on the hub →131 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 9 started in 2026.
Median enrollment 98 across the 107 interventional studies, 138 across the 24 observational. Of the 78 that completed or were terminated, 40 (51%) have results posted.
109 of 131 have an industry lead sponsor. The 10 most frequent:
Biojiva LLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Biojiva LLC has 1 study filed under Geographic Atrophy — fewer than ten, so there is no comparison to draw.
12 of the studies in Geographic Atrophy with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05949593Phase 3Belite Bio, IncPhase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy | 2027-06-30 |
| NCT06510816Phase 3Annexon, Inc.A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) | 2027-07-31 |
| NCT06769048Boehringer IngelheimA Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy | 2026-12-22 |
| NCT07747662University of Wisconsin, MadisonAdaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study | 2027-02 |
| NCT07144137Complement TherapeuticsA Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) | 2027-03-31 |
Among the 131 studies in Geographic Atrophy with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
5. History of vitrectomy surgery, submacular surgery, other surgical intervention for AMD, corneal transplant, glaucoma filtration surgery, or cataract surgery within 3 months prior to First Treatment Visit (Randomization).
6. History of intravitreal injection of anti-vascular endothelial growth factor (VEGF) therapies in the study eye at any time, history of intravitreal injection of any agent (e.g., triamcinolone) in the study eye within the last 3 months prior to study enrollment. A single intraoperative administration of a during cataract surgery at least 3 months prior to Screening is permitted.
7. History of laser therapy in the macular region in the study eye, prior treatment with photobiomodulation, external-beam radiation therapy or transpupillary thermotherapy in study eye.
8. Previous cell-based intraocular treatment in the study eye or previous expression vector-mediated intraocular treatments in either eye (i.e., gene therapy), any previous treatment with any deuterated molecules for eye diseases (e.g., deuterated vitamin A).
9. History of idiopathic or -associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease. Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis.
11. Active within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to (≤) 6, and a stable prostate-specific antigen for greater than or equal to (≥) 12 months.
13. Intake of omega-3 supplements (e.g., fish oil, cod liver oil, krill oil, edible algae oil, flax oil) or prescription omega-3 drugs (e.g., Lovaza® , Vascepa® , Epanova® ) in the past 4 weeks prior to First Treatment Visit (Randomization) and throughout the duration of the study.
14. Participation in an interventional clinical study within the past 30 days of Screening, or interventional GA studies within the past 5 months prior to Screening.
15. Treatment with SYFOVRE® or IZERVAY® within 3 months prior to First Treatment Visit (Randomization) and throughout participation in the trial. Patients who initiate any other GA treatment during the study must be discontinued.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BRX011
Drug: Placebo
Subjects will ingest BRX011 orally, as capsules.
Subjects will ingest Placebo orally, as capsules.
Annual rate of change in the square root of GA area
Annual rate of change in the square root of GA area assessed by FAF
Time frame: Baseline (Day 0) to Week 96
Change in low luminance deficit
Time frame: Baseline (Day 0) to Week 96
Change in ETDRS BCVA
Time frame: Baseline (Day 0) to Week 96
Start is estimated for Sep 2026; primary completion for Apr 2029, 31 months later.
How these figures are worked out, and which studies are left out of them.
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