Recruiting

Observational Study

Sponsor:

Nanoscope Therapeutics Inc.

Code:

NCT06805474

Conditions

Macular Degeneration

Geographic Atrophy

Stargardt Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observational

Study Details

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.

Conditions

Macular Degeneration

Geographic Atrophy

Stargardt Disease

Study ID

NCT06805474

Start date

Jan 28, 2025

Status verified date

Mar, 2025

Completion date

May 27, 2025

Anticipated

Primary completion date

May 20, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1:

Normal-Sighted Participants with clinically normal ocular findings and BCVA range 20/16 to <20/40 (ETDRS letter score 71 - 90) in each eye.

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.

Interventions

Observational

Observational

Primary outcome measure

  • MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT [ Time Frame: 15 days ]

Central Contacts and Locations

Central contacts

Nozhat Choudry, Ph.D

(817) 857-1186nchoudry@nanostherapeutics.com

Locations

Retina of North Texas,

Recruiting

Dallas, Texas, United States, 75243

More Information

Sponsor

Nanoscope Therapeutics Inc.

Last update posted

Mar 24, 2025

Last verified

Mar, 2025

Keywords

  • Multi-Luminance Shape Discrimination Test
  • low-vision magnifying aid (eGlasses)
  • best-corrected visual acuity (BCVA)
  • Early Treatment Diabetic Retinopathy Study ETDRS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nanoscope Therapeutics Inc. on 2025-03-24.