Dry AMDPhase 2/3ReBUILDNCT07927010
A Clinical Trial to Evaluate the Efficacy and Safety of Bevemipretide Ophthalmic Topical Solution in Subjects Who Have Dry Age-Related Macular Degeneration (Dry AMD)
A Phase 2/3 study testing 1 % Bevemipretide and 2% Bevemipretide in people with Dry AMD and Age-Related Macular Degeneration (AMD), run by Mighty Therapeutics, Inc..
Trial summary
Approximately 300 subjects with eligible dry AMD will be randomized to one of three groups (low dose Bevemipretide, high dose Bevemipretide, or vehicle) to receive daily ophthalmic solution administration for 48 weeks. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dry AMD, Age-Related Macular Degeneration (AMD)
- What is being tested?
- 1 % Bevemipretide and 2% Bevemipretide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 55 years of age with dry AMD.
- Imaging Conditions - Study Eye (as determined by the central Reading Center at the Screening Visit):
- GA in the study eye may be multi-focal, but the cumulative GA lesion and size (by Fundus Autofluorescence [FAF]) must be ≥ 0.50 mm2 and ≤ 10.16 mm2.
- Well-demarcated GA in the study eye that is extrafoveal (≥150 μm from foveal center), assessed by FAF.
- GA that resides completely within the FAF 30- or 35-degree image.
- Observable hyper-FAF at the margins of the GA in the study eye.
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- The absence of any retinal pathology in the study eye that prohibits outer retinal quantification and EZ mapping.
- Ocular Conditions - Study Eye:
- BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) score of ≥ 55 letters in the study eye.
- LL BCVA by ETDRS score of ≥ 10 letters in the study eye.
- LLD (defined as the difference between BCVA and LL BCVA) of ≥ 6 letters in the study eye.
- Sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and ability to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment in the study eye.
- Note: The fellow eye may have any of the following: no AMD, AMD without GA, AMD with GA, CNV AMD, or foveal GA.
- Systemic and General Criteria:
- Able to demonstrate ability to administer IMP or have an appropriate designee (i.e., a capable family member or a caregiver) who can demonstrate ability to administer IMP.
- Able to provide informed consent and willing to comply with all site visits, examinations, daily IMP administrations and dosing diary entries, and other conditions of the trial protocol.
- Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until 28 days after the last dose of IMP:
- Abstinence, when it is in line with the preferred and usual lifestyle of the subject; Subject agrees to use a highly effective method of contraception should they become sexually active.
- Relationships with male partners who have been surgically sterilized by vasectomy (the vasectomy procedure must have been conducted at least 60 days prior to the Screening Visit).
- Barrier method (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream AND either hormonal contraception (oral, implanted, or injectable) or an intrauterine device or system.
- Note: Non-childbearing potential is defined as surgical sterilization (e.g., bilateral oophorectomy, hysterectomy, or tubal ligation or postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to the Screening Visit).
- Male subjects with female partners of childbearing potential must be willing to use a highly effective method of contraception (e.g., abstinence, dual method of contraception) from the date they sign the ICF until 28 days after the last dose of IMP.
Who cannot join
- Ocular Conditions - Study Eye:
- Presence of atrophic retinal disease of causality other than AMD including myopia-related maculopathy and monogenetic macular dystrophies including pattern dystrophy and adult-onset Stargardt disease in the study eye.
- Evidence of exudative AMD or CNV in the study eye either by history, or by Fluorescein Angiography (FA) as determined by the Reading Center at Screening.
- History or presence of retinal vein occlusion in the study eye.
- Presence of vitreous hemorrhage in the study eye.
- History or presence of retinal detachment in the study eye.
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- History or presence of macular hole (stages 2 to 4) in the study eye.
- Presence of an epiretinal membrane in the study eye that may impact visual acuity, in the opinion of the Investigator.
- Presence of vitreomacular traction in the study eye.
- Presence of any clinically significant corneal pathology in the study eye, including but not limited to corneal scarring, edema, dystrophy, degeneration, or other corneal abnormality that, in the opinion of the Investigator, could interfere with ocular safety, study assessments, and endpoints.
- Severe dry eye disease, in the opinion of the Investigator.
- Inability to obtain Color Fundus Photography (CFP), FAF, and FA of sufficient quality to be analyzed and interpreted.
- Advanced glaucoma resulting in a cup to disc ratio of > 0.8 in the study eye.
- Uncontrolled glaucoma in the study eye, in the opinion of the Investigator.
- History of glaucoma filtration surgery in the study eye. Note: Minimally invasive glaucoma surgeries (e.g., MIGS) are allowable
- Presence of visually significant cataract OR presence of significant posterior capsular opacity in the setting of pseudophakia, in the study eye.
- Note: Significant cataract is defined as ≥ +3 nuclear sclerosis based upon the scale below or any Posterior Subcapsular Cataract in the study eye. The Sponsor, or its designee, will supply the clinical trial sites with a copy of the standard photographs.
- Grade Description
- 1 Opacity is absent
- 2 Opacity is present, but less than Nuclear Standard Photograph #2
- 3 Opacity is present, and as severe as or worse than Nuclear Standard Photograph #2 Source: (Chew 2010)
- Presence of significant keratopathy or any other media or corneal opacity that would cause scattering of light or alter visual function in the study eye, especially in low luminance (LL) conditions.
- Ocular incisional or laser surgery (including cataract surgery) in the study eye within 90 days before the Baseline Visit.
- YAG laser capsulotomy in the study eye within 30 days before the Baseline Visit.
- Aphakia or a secondary intraocular lens implant lacking an intact capsular bag, in the study eye.
- History of vitrectomy surgery, submacular surgery, or any vitreoretinal surgery in the study eye.
- Prior treatment with Visudyne® (verteporfin) ocular photodynamic therapy, external-beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy in the study eye.
- History of subthreshold laser treatment in the study eye.
- Photobiomodulation therapy in the study eye in the past 6 months from the Baseline Visit.
- Intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, or device implantation), except for a complement inhibitor, in the study eye.
- Oral or intravitreal drug delivery of a complement inhibitor in the study eye in the past 6 months from the Baseline Visit.
- Concurrent disease in the study eye that could require medical or surgical intervention during the trial.
- Ocular Conditions - Either Eye:
- History or presence of diabetic retinopathy in either eye (a history of diabetes mellitus without retinopathy is not a criterion for exclusion).
- History or presence of herpetic infection in either eye.
- History or presence of uveitis and/or vitritis (grade trace or above) in either eye.
- History or presence of idiopathic or autoimmune-associated uveitis in either eye.
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- Systemic and General Conditions:
- History of solid organ transplant.
- Any disease or medical condition that in the opinion of the Investigator would prevent the subject from successfully participating in the trial or might confound trial results.
- Current use of medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine [Plaquenil®], tamoxifen, phenothiazines, ethambutol, digoxin, and aminoglycosides) or causing ocular surface medicamentosa.
- Women who are pregnant, planning to become pregnant, or breastfeeding/lactating.
- History of allergy to fluorescein that is not amenable to treatment.
- Inability to comply with trial or follow-up procedures.
- Active malignancy or any other cancer from which the subject has been cancer-free for < 2 years. Localized squamous or non-invasive basal cell skin carcinomas are allowed, if appropriately treated prior to Screening.
- History of allergic reaction to the IMP or any of its components.
- Participation in other investigational drug or device clinical trials within 30 days or 5 half-lives (whichever is longer) of Screening; or is currently enrolled in a non-interventional clinical trial that, in the opinion of the Investigator, may be potentially confounding to the results of the current trial.
- Prior participation in any elamipretide or bevemipretide trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2/3, Randomized, Double-Masked, Vehicle-Controlled, Dose-Ranging Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Bevemipretide Ophthalmic Topical Solution in Subjects Who Have Dry Age-Related Macular Degeneration (Dry AMD)
Approximately 300 subjects with eligible dry AMD will be randomized to one of three groups (low dose Bevemipretide, high dose Bevemipretide, or vehicle) to receive daily ophthalmic solution administration for 48 weeks.
Read the detailed description
In this Phase 2/3, randomized, double-masked, parallel-group, vehicle-controlled, dose-ranging trial to evaluate the efficacy and safety of once daily bevemipretide ophthalmic topical solution administered for 48 weeks as a treatment for subjects who have dry AMD, approximately 300 subjects will be randomized (1:1:1 ratio) to one of three groups:
- 1 drop of 1% bevemipretide ophthalmic topical solution instilled only in study eye once daily (Low-Dose) OR
- 1 drop of 2% bevemipretide ophthalmic topical solution instilled only in study eye once daily (High-Dose) OR
- 1 drop vehicle instilled only in study eye once daily (Vehicle)
The trial duration is up to 56 weeks, which includes up to a 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-Up Period.
- Conditions
- Dry AMD, Age-Related Macular Degeneration (AMD)
- Being tested
- 1 % Bevemipretide, 2% Bevemipretide, Vehicle
- Keywords
- Bevemipretide, Dry AMD, Age-Related Macular Degeneration, Geographic Atrophy
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 % BevemipretideDrug
Low Dose 1% bevemipretide ophthalmic topical solution
2% BevemipretideDrug
High Dose 2% bevemipretide ophthalmic topical solution
VehicleOther
Vehicle for this trial will be composed of sodium chloride and phosphate buffer, similar to excipients used to manufacture the active drug, but without the active drug substance.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose (1%) Bevemipretide | Experimental | 1 drop of 1% bevemipretide ophthalmic topical solution instilled only in study eye once daily (Low-Dose) Receives: Drug: 1 % Bevemipretide |
| High Dose (2%) Bevemipretide | Experimental | 1 drop of 2% bevemipretide ophthalmic topical solution instilled only in study eye once daily (High-Dose) Receives: Drug: 2% Bevemipretide |
| Vehicle | Placebo comparator | 1 drop vehicle instilled only in study eye once daily (Vehicle) Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Change in Macular Area of Photoreceptor Loss through week 48
Rate of change in the macular area of photoreceptor loss (defined as an Ellipsoid Zone - Retinal Pigment Epithelium (EZ-RPE) thickness of 0μm) through Week 48, assessed by spectral domain optical coherence tomography (SD-OCT) and Ellipsoid Zone (EZ) mapping
Measured: 48 Weeks
Secondary outcomes (12)
Rate of Change in the macular area of partial photoreceptor loss
Rate of change in the macular area of partial photoreceptor loss (defined as an EZ-RPE thickness of ≤ 20 μm) through Week 48, assessed by SD-OCT and EZ mapping
Measured: 48 Weeks
Proportion of Subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best Corrected Visual Acuity (LL BCVA) from baseline
Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best Corrected Visual Acuity (LL BCVA) from baseline at Week 48, assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Measured: 48 Weeks
Proportion of subjects gaining ≥ 15 letters (3 lines) in LL BCVA from baseline
Proportion of subjects gaining ≥ 15 letters (3 lines) in LL BCVA from baseline at Week 48, assessed by the ETDRS chart
Measured: 48 Weeks
Change in low luminance quantitative contrast sensitivity function
Change from baseline in low luminance quantitative contrast sensitivity function (qCSF) at Week 48
Measured: 48 weeks
Proportion of subjects gaining ≥ 5 letters (1 line) in LL BCVA at week 48
Proportion of subjects gaining ≥ 5 letters (1 line) in LL BCVA from baseline at Week 48, assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Measured: 48 Weeks
Proportion of subjects losing < 5 letters (1 line) in LL BCVA at Week 48,
Proportion of subjects losing < 5 letters (1 line) in LL BCVA from baseline at Week 48, assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Measured: 48 weeks
Proportion of subjects losing < 10 letters (2 lines) in LL BCVA at Week 48
Proportion of subjects losing < 10 letters (2 lines) in LL BCVA from baseline at Week 48, assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Measured: 48 weeks
Proportion of subjects losing < 15 letters (3 lines) in LL BCVA at Week 48
Proportion of subjects losing < 15 letters (3 lines) in LL BCVA from baseline at Week 48, assessed by the ETDRS chart
Measured: 48 weeks
Change in LL BCVA letter score at Week 48
Change in LL BCVA letter score from baseline at Week 48, assessed by the ETDRS chart
Measured: 48 weeks
Change in LL BCVA Deficit at Week 48
Change in LL BCVA Deficit (LLD, defined as the difference between BCVA and LL BCVA) from baseline at Week 48, assessed by the ETDRS chart
Measured: 48 weeks
Change in standard luminance qCSF at Week 48
Change from baseline in standard luminance qCSF at Week 48
Measured: 48 weeks
Safety Assessments: Incidence and Severity of adverse Events
Report the # of subjects with adverse events and incidence and severity of such adverse events (AEs)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-masked, parallel-group, vehicle-controlled, dose-ranging trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mighty Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07927010
- Sponsor's protocol ID
- MYTX272AM-201
- Acronym
- ReBUILD
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Double-Masked, Vehicle-Controlled, Dose-Ranging Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Bevemipretide Ophthalmic Topical Solution in Subjects Who Have Dry Age-Related Macular Degeneration (Dry AMD)
- ClinicalTrials.gov ID
- NCT07927010
- Acronym / sponsor ID
- ReBUILD / MYTX272AM-201
- Conditions
- Dry AMD, Age-Related Macular Degeneration (AMD)
- Keywords
- Bevemipretide, Dry AMD, Age-Related Macular Degeneration, Geographic Atrophy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mighty Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 300 subjects with eligible dry AMD will be randomized to one of three groups (low dose Bevemipretide, high dose Bevemipretide, or vehicle) to receive daily ophthalmic solution administration for 48 weeks.
Detailed description
In this Phase 2/3, randomized, double-masked, parallel-group, vehicle-controlled, dose-ranging trial to evaluate the efficacy and safety of once daily bevemipretide ophthalmic topical solution administered for 48 weeks as a treatment for subjects who have dry AMD, approximately 300 subjects will be randomized (1:1:1 ratio) to one of three groups:
- 1 drop of 1% bevemipretide ophthalmic topical solution instilled only in study eye once daily (Low-Dose) OR
- 1 drop of 2% bevemipretide ophthalmic topical solution instilled only in study eye once daily (High-Dose) OR
- 1 drop vehicle instilled only in study eye once daily (Vehicle)
The trial duration is up to 56 weeks, which includes up to a 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-Up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-masked, parallel-group, vehicle-controlled, dose-ranging trial
| Arm | Type | Receives |
|---|---|---|
| Low Dose (1%) Bevemipretide | Experimental | Drug: 1 % Bevemipretide1 drop of 1% bevemipretide ophthalmic topical solution instilled only in study eye once daily (Low-Dose) |
| High Dose (2%) Bevemipretide | Experimental | Drug: 2% Bevemipretide1 drop of 2% bevemipretide ophthalmic topical solution instilled only in study eye once daily (High-Dose) |
| Vehicle | Placebo comparator | Other: Vehicle1 drop vehicle instilled only in study eye once daily (Vehicle) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Adults ≥ 55 years of age with dry AMD.
- Imaging Conditions - Study Eye (as determined by the central Reading Center at the Screening Visit):
- GA in the study eye may be multi-focal, but the cumulative GA lesion and size (by Fundus Autofluorescence [FAF]) must be ≥ 0.50 mm2 and ≤ 10.16 mm2.
- Well-demarcated GA in the study eye that is extrafoveal (≥150 μm from foveal center), assessed by FAF.
- GA that resides completely within the FAF 30- or 35-degree image.
Key exclusion criteria (49 listed)
- Presence of atrophic retinal disease of causality other than AMD including myopia-related maculopathy and monogenetic macular dystrophies including pattern dystrophy and adult-onset Stargardt disease in the study eye.
- Evidence of exudative AMD or CNV in the study eye either by history, or by Fluorescein Angiography (FA) as determined by the Reading Center at Screening.
- History or presence of retinal vein occlusion in the study eye.
- Presence of vitreous hemorrhage in the study eye.
- History or presence of retinal detachment in the study eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 % BevemipretideLow Dose 1% bevemipretide ophthalmic topical solution | Drug | Low Dose (1%) Bevemipretide |
| 2% BevemipretideHigh Dose 2% bevemipretide ophthalmic topical solution | Drug | High Dose (2%) Bevemipretide |
| VehicleVehicle for this trial will be composed of sodium chloride and phosphate buffer, similar to excipients used to manufacture the active drug, but without the active drug substance. | Other | Vehicle |
Primary outcome
Rate of Change in Macular Area of Photoreceptor Loss through week 48
Time frame: 48 Weeks
Rate of change in the macular area of photoreceptor loss (defined as an Ellipsoid Zone - Retinal Pigment Epithelium (EZ-RPE) thickness of 0μm) through Week 48, assessed by spectral domain optical coherence tomography (SD-OCT) and Ellipsoid Zone (EZ) mapping
12 secondary outcomes
Rate of Change in the macular area of partial photoreceptor loss
Time frame: 48 Weeks
Proportion of Subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best Corrected Visual Acuity (LL BCVA) from baseline
Time frame: 48 Weeks
Proportion of subjects gaining ≥ 15 letters (3 lines) in LL BCVA from baseline
Time frame: 48 Weeks
Change in low luminance quantitative contrast sensitivity function
Time frame: 48 weeks
Proportion of subjects gaining ≥ 5 letters (1 line) in LL BCVA at week 48
Time frame: 48 Weeks
Proportion of subjects losing < 5 letters (1 line) in LL BCVA at Week 48,
Time frame: 48 weeks
Proportion of subjects losing < 10 letters (2 lines) in LL BCVA at Week 48
Time frame: 48 weeks
Proportion of subjects losing < 15 letters (3 lines) in LL BCVA at Week 48
Time frame: 48 weeks
Change in LL BCVA letter score at Week 48
Time frame: 48 weeks
Change in LL BCVA Deficit at Week 48
Time frame: 48 weeks
Change in standard luminance qCSF at Week 48
Time frame: 48 weeks
Safety Assessments: Incidence and Severity of adverse Events
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 1 % Bevemipretide and 2% Bevemipretide in people with Dry AMD and Age-Related Macular Degeneration (AMD), run by Mighty Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rekha Sathyanarayana (617-762-2579, rekha.sathyanarayana@stealthbt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Change in Macular Area of Photoreceptor Loss through week 48 (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.