A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT

Recruiting

• Conditions: Macular Degeneration; Geographic Atrophy; Stargardt Disease

• Registration Number: NCT06805474
• Lead Sponsor: Nanoscope Therapeutics Inc.

Brief Summary

The goal of this observational study is to assess the reliability and validity of the 9-object MLSDT for evaluation of participants with moderate to severe vision impairment when tested without a wearable low-vision magnifying aid (eGlasses) and then with eGlasses. These results will be compared to ETDRS testing results for the same participants without eGlasses and then with eGlasses. Two cohorts will consist of participants who have vision loss due to STGD or geographic atrophy (GA) due to age-related macular degenerations (AMD). Normally sighted participants will provide a control group.

Detailed Description

Here, we aim to test the accuracy and validate the MLSDT using 9 shapes (instead of 3 shapes) as a reliable, standardized and efficient test of functional vision in STGD and GA patients with impaired vision. This includes evaluation of the performance (retest variability and repeatability) of the test(s) based on patients' visual acuity. Furthermore, we will explore descriptive relationships between MLSDT with best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study ETDRS) eye chart.

Study Timeline

• Study Start: 2025-01-28
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-02-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-05-20
• Study Completion: 2025-05-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Males and females, age ≥ 18 years
• Able to comprehend and give informed consent.
• Able to comply with testing and all protocol tests.
• Eligible for 1 of 3 cohorts listed below:

Cohort 1: Normal-Sighted Participants with clinically normal ocular findings and BCVA range 20/16 to <20/40 in each eye (ETDRS letter score 71 - 90) Cohort 2: Moderately-Sight Impaired Participants with a BCVA range of 20/40 to <20/200 (ETDRS letter score of 36 - 70) and a clinical diagnosis of STGD/GA Cohort 3: Severely-Sight Impaired Participants with a BCVA range of 20/200 to 20/800 (ETDRS letter score of 5 - 35) and a clinical diagnosis of advanced STGD/GA

• Clinical diagnosis of STGD for cohorts 2 and 3
• Clinical diagnosis for GA (due to AMD) for cohorts 2 and 3
• Participants who have had anti-VEGF therapy 2 weeks prior to enrollment have to demonstrate 3 months of vision stability and be fluid free on OCT.

Exclusion Criteria

• Concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months

  • Presence of any condition other than STGD or GA from AMD on slit lamp exam or dilated ophthalmoscopy that impairs visual acuity or visual fields e.g., corneal opacity, visually significant cataract or visual field loss in glaucoma
  • No intra-vitreal injection with anti-VEGF two weeks prior to the study
  • Presence of neurological condition that impairs visual acuity
  • Individuals who refuse or are incapable of performing the MLSDT of BCVA tests
  • Individuals with retinal prosthesis (such as ARGUS-II)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT	15 days	Comparison of vision test scores against the ETDRS visual acuity test

Trial Locations

Locations (1)

Retina of North Texas,; 🇺🇸 Dallas, Texas, United States