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NCT05674058Active, not recruiting

Function and Imaging Assessments for G1961E-associated Stargardt Disease

Function and Imaging Assessments for G1961E-associated Stargardt Disease: Outcome Measure Ranking as Basis for Interventional Trials

Source: ClinicalTrials.gov · Last updated 22 Apr 2025

Brief summary (registry, in English)

Some phenotypes of Stargardt disease are rather distinct. This includes the 'bull's eye maculopathy' phenotype associated with the frequent ABCA4 G1961E variant. In anticipation of a treatment trial, this natural history study aims to compare functional and structural outcome measures systematically.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
20 (estimated)
First submitted
21 Dec 2022
Start date
1 Nov 2022
Primary completion date
31 Oct 2025
Lead sponsor
University Hospital, Basel, Switzerland
NCT number
NCT05674058

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From 1 Nov 2022 to the primary completion date, 31 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior surgery (other than anti-VEGF injections, cataract surgery, YAG laser capsulotomy, or laser retinopexy) that - according to the investigator's judgment - may affect visual function assessments (e.g., retinal detachment surgery, glaucoma filtration surgery, or a history of a corneal transplant in the study-eye)
  • Concurrent ophthalmic conditions in the study eye that (according to the investigator's judgment) may contribute to loss of vision such as clinically significant opacification of the ocular media (corneal dystrophies, cataract), other retinal diseases, or disease of the optic nerve head and visual pathway (including amblyopia)
  • Major surgery planned or other events that (according to the investigator's judgment) could hinder follow-up examinations (e.g., knee replacement)

Other

  • Inability to give informed consent

Who the study is looking for

  • Adult patients with G1961E-associated Stargardt disease
  • Defined by (1.) the presence of two pathogenic ABCA4 variants with at least one ABCA4G1961E variant, (2.) a Stargardt disease phenotype, and (3.) the absence of pathogenic variants in PRPH2, PROM1, and ELOVL4

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Basel
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.