Clinical trials: Stargardt Macular Dystrophy
STGD1, Stargardt Disease 1
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease
- Trial name
- DRAGON II (NCT06388083)
- Testing
- Tinlarebant
- Where
- 18 sites in United States, Japan and 1 more
- Volunteers
- 60 people
- Sponsor
- Belite Bio, Inc
Stargardt Disease, Stargardt Disease 1
Prescreening Study to Identify Potential Stargardt Participants for ACDN-01 Clinical Trials (STARPATH)
This is an observational prescreening study. Individuals who are eligible for prescreening will undergo testing procedures that may be used to determine eligibility in ACDN-01 clinical trials.
- Conditions
- Stargardt Disease, Stargardt Disease 1, Cone Rod Dystrophy, Juvenile Macular Degeneration
- Trial name
- NCT06445322
- Testing
- Prescreening Assessments
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Ascidian Therapeutics, Inc
Stargardt's Disease
Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration
Primary Objective: To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardt's Macular Degeneration (SMD). Secondary Objective: To evaluate for possible biological activity of SAR422459.
- Trial name
- NCT01367444
- Testing
- SAR422459
- Where
- 5 sites in United States, France
- Volunteers
- 27 people
- Sponsor
- Sanofi
Stargardt Disease
A Study of DC6001 Tablet in Healthy Chinese Adult Subjects
This study adopts a randomized, double-blind, parallel placebo-controlled dose-escalation design, consisting of two parts: Part 1 includes a single ascending dose (SAD) study plus a food effect (FE) study, and Part 2 is a…
- Trial name
- NCT07417566
- Testing
- DC6001
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Heronova Pharmaceuticals
Stargardt Disease
A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease
Phase 2/3 Pivotal Confirmatory Clinical Trial is a randomized, outcome assessor-masked, multicenter study, that will enroll fifty-one (51) subjects.
- Trial name
- GARDian3 (NCT05956626)
- Testing
- OCU410ST
- Where
- 14 sites in United States
- Volunteers
- 51 people
- Sponsor
- Ocugen
Stargardt Disease
This is a Dose-finding Study Followed by 2-year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Adolescent Subjects With Stargardt Disease
Stargardt disease 1 (STGD1) is the most prevalent form of juvenile macular degeneration. It is caused by a rare, inherited autosomal recessive trait, leading to severe and irreversible blindness by the first or second decade of…
- Trial name
- NCT05266014
- Testing
- tinlarebant
- Where
- 3 sites in Australia, Taiwan
- Volunteers
- 13 people
- Sponsor
- RBP4 Pty Ltd
Macular Degeneration, Geographic Atrophy
A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
The goal of this observational study is to assess the reliability and validity of the 9-object MLSDT for evaluation of participants with moderate to severe vision impairment when tested without a wearable low-vision magnifying…
- Conditions
- Macular Degeneration, Geographic Atrophy, Stargardt Disease
- Trial name
- NCT06805474
- Testing
- Observational
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nanoscope Therapeutics Inc.
Stargardt Disease
Non-interventional Long Term Follow-up Study of Participants Previously Enrolled in the STARLIGHT Study
The current study is a non-interventional long-term safety follow-up of the subjects who completed STARLIGHT, in accordance with FDA guidance on recipients of human gene therapy products.
- Trial name
- SUSTAIN (NCT06048185)
- Testing
- Gene Therapy Product-MCO-010
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Nanoscope Therapeutics Inc.
Retinitis Pigmentosa, Stargardt Macular Dystrophy
Development and Evaluation of Functional Visual Field and Navigation Endpoints in Moderate to Profound Inherited Retinal Disease (DEFINE-IRD)
The Vision Research and Assessment Institute (VRAI) was established with the purpose of serving as a testing facility for efficacy endpoints for patients with Low Vision.
- Conditions
- Retinitis Pigmentosa, Stargardt Macular Dystrophy, Stargardt Disease, Geographic Atrophy From Age-related Macular Degeneration
- Trial name
- DEFINE-IRD (NCT07502664)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Ray Therapeutics, Inc.
Stargardt's Macular Dystrophy
Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macular Dystrophy
This is a safety and tolerability trial to evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with Stargardt's Macular Dystrophy (SMD).
- Trial name
- NCT01345006
- Testing
- MA09-hRPE
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Astellas Institute for Regenerative Medicine
Stargardt Disease
A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)
The purpose of the 039-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-039 in participants with Stargardt disease secondary to a biallelic mutation of the ABCA4 gene.
- Trial name
- CELESTE (NCT07161544)
- Testing
- AAVB-039
- Where
- 11 sites in United States, Norway and 1 more
- Volunteers
- 75 people
- Sponsor
- AAVantgarde Bio Srl
Stargardt's Disease
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
Primary Objective: To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration. Secondary Objective: To assess: Safety Biological activity
- Trial name
- NCT01736592
- Testing
- Long term follow up in all patients who received SAR422459 in previous study TDU13583
- Where
- 2 sites in United States, France
- Volunteers
- 27 people
- Sponsor
- Sanofi
Retinal Disease, Age-Related Macular Degeneration
Stem Cell Ophthalmology Treatment Study II
This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.
- Conditions
- Retinal Disease, Age-Related Macular Degeneration, Retinitis Pigmentosa, Stargardt Disease
- Trial name
- SCOTS2 (NCT03011541)
- Testing
- Arm 1
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 500 people
- Sponsor
- MD Stem Cells
Stargardt Disease, Stargardt Macular Dystrophy
A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults
Macular dystrophies are a group of inherited eye conditions that affect the macula. The macula is in the center of the retina, the light sensitive part at the back of the eye.
- Conditions
- Stargardt Disease, Stargardt Macular Dystrophy, Stargardt-like Macular Dystrophy
- Trial name
- EVOLVE (NCT07425574)
- Testing
- No Intervention
- Where
- 15 sites in United States
- Volunteers
- 90 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Stargardt Disease, Cone Rod Dystrophy
Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)
This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and…
- Conditions
- Stargardt Disease, Cone Rod Dystrophy, Juvenile Macular Degeneration, Stargardt Disease 1
- Trial name
- NCT06467344
- Testing
- ACDN-01
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Ascidian Therapeutics, Inc
Stargardt Disease, Age-related Macular Degeneration
Phase 1 Safety Study of ALK-001 in Healthy Volunteers
This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.
- Conditions
- Stargardt Disease, Age-related Macular Degeneration, Other Retinal Dystrophies
- Trial name
- NCT02230228
- Testing
- ALK-001 (No generic name)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alkeus Pharmaceuticals, Inc.
Stargardt Disease, Stargardt Macular Dystrophy
A Study About the Safety of a Single ASP2020 Eye Injection and if it Helps People With Vision Loss From Stargardt-type Eye Conditions
Macular dystrophies are a group of inherited eye conditions that affect the macula. The macula is in the center of the retina, the light sensitive part at the back of the eye.
- Conditions
- Stargardt Disease, Stargardt Macular Dystrophy, Stargardt-like Macular Dystrophy
- Trial name
- DEVOTE (NCT07734064)
- Testing
- ASP2020
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Astellas Institute for Regenerative Medicine
Stargardt Disease-1
Study of STG-001 in Subjects With Stargardt Disease
This is an open-label, multicenter study in subjects with Stargardt disease, comparing 2 doses of STG-001 with regard to safety, pharmacokinetics and pharmacodynamics.
- Trial name
- NCT04489511
- Testing
- STG-001
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Stargazer Pharmaceuticals, Inc.
Stargardt Disease
Study of ALK-001 on the Progression of Stargardt Disease
This study evaluates the efficacy and safety of investigational study drug ALK-001 in participants 8 to 45 years of age, inclusive, with symptoms and signs of autosomal recessive Stargardt disease (STGD)
- Trial name
- NORTHSTAR (NCT07419334)
- Testing
- ALK-001
- Where
- 14 sites in United States
- Volunteers
- 230 people
- Sponsor
- Alkeus Pharmaceuticals, Inc.
Geographic Atrophy, Stargardt Disease
Phase 1 Study of C.001 in Retinal Degeneration
This is a first-in-human Phase 1 study evaluating the safety and tolerability of C.001 in patients with retinal diseases involving degeneration of the retinal pigment epithelium.
- Conditions
- Geographic Atrophy, Stargardt Disease, RPE-mediated Maculopathy, Age Related Macular Degeneration
- Trial name
- NCT07594236
- Testing
- Injection
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cellio Therapeutics Inc