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Gene Therapy
Gene Therapy-vMCO-010 for Fundus Flavimaculatus (STARLIGHT Trial)
Phase 2
Waitlist Available
Research Sponsored by Nanoscope Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
Summary
This trial will test if a single injection of vMCO-010, a virally-carried opsin, is safe and effective in treating Stargardt Disease.
Eligible Conditions
- Fundus Flavimaculatus
- Stargardt Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Secondary outcome measures
Effect of vMCO-010 as assessed by visual acuity
Effect of vMCO-010 on Light-guided Mobility
Effect of vMCO-010 on determination of optical flow
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Experimental-vMCO-010Experimental Treatment1 Intervention
Participants receive 1.2E11gc/eye of vMCO-010
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gene Therapy-vMCO-010
2022
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Nanoscope Therapeutics Inc.Lead Sponsor
6 Previous Clinical Trials
108 Total Patients Enrolled
Aaron Osborne, MDStudy DirectorNanoscope Therapeutics Inc.
1 Previous Clinical Trials
27 Total Patients Enrolled
Dr Samarendra MohantyStudy DirectorNanoscope Therapeutics Inc.
2 Previous Clinical Trials
62 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received gene therapy, stem cell therapy, or certain types of eye surgeries involving implants or injections in the past.You have other serious health conditions, like cancer, that could affect how your brain works.You are currently taking medications that can harm your eyesight, like hydroxychloroquine or chloroquine.You have taken a vitamin A medication as part of another study within the last 3 months.You have a serious heart or blood vessel condition, including a recent stroke within the past year.You have a serious medical or psychiatric condition, abnormal physical exam findings, or abnormal lab results, according to the doctor's evaluation.Your eye has a narrow angle that makes it unsafe to dilate your pupil for the study.In the study eye: BCVA no better than 20/200 in the fellow eye.You have certain eye conditions like glaucoma or diseases that cause loss of vision.You have had eye surgery or laser treatment on your eyes within the past 3 months, or you have had laser treatment in the central part of your eye in the past.You have an eye condition that could affect the results of the study. If you've had cataract surgery and it was successful, you can participate after waiting for three months.You have a history of uncontrolled diabetes, hepatitis, pancreatitis, liver problems, thyroid issues, or excessive vitamin A levels.You are allergic to the dye used in certain eye tests, povidone iodine, or the ingredients in the vMCO-010 medication.You have ongoing eye inflammation or a history of recurring eye inflammation without a known cause or related to an autoimmune condition.You have eye conditions that could affect your vision and eye tests during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental-vMCO-010
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