Clinical trials: Stargardt Disease Type 1 (STGD1)
Low Vision, Retinitis Pigmentosa
Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
Purpose: To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality.
- Conditions
- Low Vision, Retinitis Pigmentosa, Stargardt Disease 1, Stargardt Disease 3
- Trial name
- NCT04281732
- Testing
- Virtual Reality Headset based tests
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- Queen's University, Belfast
Stargardt's Macular Dystrophy
Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).
- Trial name
- NCT03364153
- Testing
- avacincaptad pegol
- Where
- 41 sites in United States, France and 6 more
- Volunteers
- 121 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Stargardt Disease 1
Safety and Efficacy of a Single Subretinal Injection of JWK006 Gene Therapy in Subjects With Stargardt Disease(STGD1)
The purpose of the study is to assess the safety and efficacy of JWK006 in Stargardt Disease(STGD1). JWK006 is packed by adeno-associated virus vector that expressing ABCA4 gene.
- Trial name
- NCT06300476
- Testing
- JWK006
- Where
- China
- Volunteers
- 9 people
- Sponsor
- West China Hospital
Stargardt, Stargardt's Disease
An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene
This is an Observational Study to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene This is a multicenter study which will enroll approximately 75…
- Conditions
- Stargardt, Stargardt's Disease, Stargardt Disease, STGD1
- Trial name
- POLARIS (NCT06435000)
- Where
- 20 sites in United States, Germany and 1 more
- Volunteers
- 75 people
- Sponsor
- Splice Bio
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
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
Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease
A Phase 1/2, open-label, non-randomized, dose-escalation study, where a minimum of 9 and a maximum of 18 eligible patients with Stargardt Disease will be enrolled sequentially in up to 3 dose cohorts of RTx-021.
- Trial name
- AURORA (NCT07439887)
- Testing
- RTx-021
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Ray Therapeutics, 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
Macular Dystrophy, Corneal
Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy
The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizol™) inhibits dark adaptation of the eye.
- Trial name
- NCT00346853
- Testing
- 4-Methylpyrazole, saline
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Utah
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
Retinal Dystrophy Due to Biallelic ABCA4 Mutations, Stargardt Disease 1
Safety and Preliminary Efficacy of VG801 in Patients With ABCA4 Mutation-associated Retinal Dystrophy (Stargardt Disease)
This is a single-arm, open-label, non-randomized, single dose-escalation, first-in-human (FIH) clinical trial to evaluate the safety and preliminary efficacy of VG801 for treatment of patients with retinal dystrophy (Stargardt…
- Trial name
- NCT07002398
- Testing
- VG801
- Where
- China
- Volunteers
- 18 people
- Sponsor
- VeonGen Therapeutics GmbH
Stargardt Disease, Stargardt Macular Degeneration
A Phase 1/2, First-in-Human Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Subretinal Injection of SB-007 in Subjects With Stargardt Disease (STGD1)
This Phase 1/2 study will evaluate the safety, tolerability, and preliminary efficacy of subretinal SB-007 administration to determine dose selection in subjects with Stargardt's Type 1 (STGD1).
- Conditions
- Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy
- Trial name
- ASTRA (NCT06942572)
- Testing
- SB-007
- Where
- 5 sites in United States
- Volunteers
- 57 people
- Sponsor
- Splice Bio
Stargardt Disease 1
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease
The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1
- Trial name
- DRAGON (NCT05244304)
- Testing
- Tinlarebant
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 104 people
- Sponsor
- Belite Bio, Inc
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
Retinal Degeneration, Retinitis Pigmentosa
Stem Cells Therapy in Degenerative Diseases of the Retina
The purpose of this study is to test the safety and effectiveness of an autologous bone marrow-derived stem/progenitor cells administered intravitreously in the subjects with degenerative diseases of the retina.
- Conditions
- Retinal Degeneration, Retinitis Pigmentosa, Age Related Macular Degeneration, Stargardt Disease 1
- Trial name
- NCT03772938
- Testing
- Stem/progenitor cells transplantation
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Pomeranian Medical University Szczecin
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.
Stargardt Disease, Stargardt Disease 1
Function and Imaging Assessments for G1961E-associated Stargardt Disease
Some phenotypes of Stargardt disease are rather distinct. This includes the 'bull's eye maculopathy' phenotype associated with the frequent ABCA4 G1961E variant.
- Conditions
- Stargardt Disease, Stargardt Disease 1, Fundus Flavimaculatus, Macular Degeneration, Stargardt
- Trial name
- FIRSTORBIT (NCT05674058)
- Testing
- No intervention
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University Hospital, Basel, Switzerland
Stargardt Disease, Stargardt Macular Degeneration
Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)
The purpose of this open-label, multicenter study is to determine the long-term safety, pharmacokinetics and effects of ALK-001 (C20-D3-retinyl acetate) on the progression of Stargardt disease.
- Conditions
- Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy, Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
- Trial name
- NCT04239625
- Testing
- ALK-001
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- Alkeus Pharmaceuticals, Inc.
Retinal Diseases, Stargardt's Disease
Microcurrent Stimulation to Treat Macular Degeneration
Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.
- Conditions
- Retinal Diseases, Stargardt's Disease, Retinitis Pigmentosa
- Trial name
- NCT01790958
- Where
- 4 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Retina Institute of Hawaii
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.