NCT06805474 A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
| NCT ID | NCT06805474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanoscope Therapeutics Inc. |
| Condition | Macular Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-28 |
| Primary Completion | 2025-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-01-28 with a primary completion date of 2025-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Samuel Barone, MD
STUDY CHAIR
Nanoscope Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT06805474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06805474 currently recruiting?
Yes, NCT06805474 is actively recruiting participants. Contact the research team at nchoudry@nanostherapeutics.com for enrollment information.
Where is the NCT06805474 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06805474 clinical trial?
NCT06805474 is sponsored by Nanoscope Therapeutics Inc.. The principal investigator is Samuel Barone, MD at Nanoscope Therapeutics Inc.. The trial plans to enroll 30 participants.