Clinical trials: Stargardt Disease
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.
Dominantly Inherited Stargardt's Disease (STGD3)
DHA Supplementation in Patients With STGD3
We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients.
- Trial name
- NCT00420602
- Testing
- Over the counter DHA/EPA dietary supplementation
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Utah
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 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
Retinal Degenerations, Retinitis Pigmentosa (RP)
Inherited Retinal Diseases: Natural History and Genotype-Phenotype Correlations
Inherited Retinal Diseases (IRDs) are a heterogeneous group of genetically based degenerative retinal disorders, representing a major cause of visual impairment and blindness in working-age adults.
- Conditions
- Retinal Degenerations, Retinitis Pigmentosa (RP), Stargardt Disease
- Trial name
- IRDs-OSR (NCT07265895)
- Testing
- No Intervention: Observational Cohort
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS San Raffaele
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.
Stargardt's Macular Dystrophy
Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients
The purpose of this study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced Stargardt's Macular Dystrophy (SMD) from one to five years following the surgical procedure to…
- Trial name
- NCT02445612
- Testing
- MA09-hRPE
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Astellas Institute for Regenerative Medicine
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.
Retinal Degeneration, Genetic Disease
Saffron Supplementation in Stargardt's Disease
The general area of research in which this project has been designed is that of retinal degeneration related to mutations in the ABCR gene, responsible of Stargardt disease/fundus flavimaculatus retinal dystrophy (STD/FF).
- Conditions
- Retinal Degeneration, Genetic Disease, Single-Gene Defects, Macular Dystrophy
- Trial name
- STARSAF02 (NCT01278277)
- Testing
- Saffron supplementation
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Catholic University of the Sacred Heart
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
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
Retinitis Pigmentosa, Choroideremia
Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Patients with Retinal Degeneration
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, Choroideremia, Stargardt Macular Dystrophy, Stargardt Disease
- Trial name
- NCT06375239
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Ray Therapeutics, Inc.
Retinal Degeneration, Retinitis Pigmentosa
Rod and Cone Mediated Function in Retinal Disease
Background: Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss and night blindness. Researchers want to learn about rod and cone function in healthy people and people with retinal…
- Conditions
- Retinal Degeneration, Retinitis Pigmentosa, Stargardt's Disease
- Trial name
- NCT02617966
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- National Eye Institute (NEI)
Stargardt Disease
Feasibility and Tolerability Study of Smart Contact Lens With Healthy Subjects and Patients With Stargardt's Disease
Oculometry is becoming increasingly popular in fields such as enhanced reality and healthcare, but remains limited by complex devices that are poorly adapted to the needs of users, particularly the visually impaired.
- Trial name
- RE-SEE (NCT06989658)
- Testing
- SCL miniaturized scleral lens positioning
- Where
- France
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Stargardt Disease, Stargardt Macular Degeneration
Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease
The purpose of this study is to determine the long term safety and tolerability of ALK-001 (C20-D3-retinyl acetate), and to explore the effects of ALK-001 on the progression of Stargardt disease in patients between the ages of 8…
- Conditions
- Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy, Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
- Trial name
- TEASE (NCT02402660)
- Testing
- ALK-001
- Where
- 14 sites in United States
- Volunteers
- 160 people
- Sponsor
- Alkeus Pharmaceuticals, Inc.
Stargardt Disease
An Observational Study in Children and Adults With Stargardt Disease
This multicenter, prospective, longitudinal, observational study in approximately 80 subjects with Stargardt disease secondary to biallelic mutations in the ABCA4 gene (STGD1) aims to evaluate prognostic factors of disease…
- Trial name
- NCT06591806
- Where
- 2 sites in United States, Norway
- Volunteers
- 80 people
- Sponsor
- AAVantgarde Bio Srl
Macular Degeneration
Effect of DHA Supplements on Macular Function in Patients With Stargardt Macular Dystrophy and Stargardt-like Macular Dystrophy
This study will evaluate whether docosahexaenoic acid (DHA) dietary supplementation can improve macular function in patients with Stargardt macular dystrophy and Stargardt-like macular dystrophy.
- Trial name
- NCT00060749
- Testing
- Docosahexaenoic Acid (DHA) Dietary Supplement
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- National Eye Institute (NEI)
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 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-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.