52 Participants Needed

Natural History Study for Best Disease

Recruiting at 3 trial locations
SH
Overseen ByStephen H Tsang, MD, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand Best Vitelliform Macular Dystrophy (VMD), an eye disorder caused by mutations in the BEST1 gene that can lead to vision loss. Researchers seek to track the natural progression of the disease to aid in designing future treatments. The study will identify reliable methods to measure changes in the eyes and compare them between both eyes to determine if one can serve as a control in future trials. It is suitable for individuals diagnosed with VMD linked to the BEST1 gene who can attend four study visits over three years. As an unphased study, this trial allows participants to contribute to foundational research that could shape future treatment strategies for VMD.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on understanding the natural history of Best Vitelliform Macular Dystrophy (VMD), a rare genetic eye disorder. Unlike treatments that aim to manage symptoms, this study seeks to uncover how the condition progresses over time, particularly in those with specific genetic variants in the BEST1 gene. By gaining a deeper understanding of the disease's progression, scientists hope to pave the way for more targeted and effective treatments in the future.

Who Is on the Research Team?

SH

Stephen H Tsang, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to provide informed consent
Diagnosis of BEST1-associated VMD by study physician, who are trained retinal specialists in the university clinic Must be able to commit to 4 follow-up study visits (3 years)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Natural History Observation

Participants are observed to report the natural history of retinal degeneration and identify outcome measures for future trials

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after the observation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Natural History Study

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Best Vitelliform Macular Dystrophy (VMD) ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Collaborator

Trials
22
Recruited
8,000+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+

Centre Hospitalier National d'Ophtalmologie

Collaborator

Trials
1
Recruited
50+

Universität Tübingen

Collaborator

Trials
30
Recruited
14,900+