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Treatment for Age-Related Macular Degeneration

N/A
Waitlist Available
Led By Jeff S. Heier, MD
Research Sponsored by Notal Vision Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month following reading center grading completion
Awards & highlights

Summary

This is a single arm study of home monitoring with the NVHO for 5 weeks with office visits at enrollment, Week 1 and Week 5 (Exit Visit) and, when applicable, Interim Visit(s) triggered by ongoing review by the Reading Center. The study will enroll subjects diagnosed with NV-AMD in at least one eye with attention to the proportion of eyes with IRF and/or SRF. The enrolled eligible subjects will be instructed to self-image the study eye(s) once daily for 5 weeks using a NVHO device at home with scheduled in-office examinations at Week 1, Week 5 and Interim Visits, when applicable, with additional in-office Cirrus volume scans acquired at these office visits. The self-imaging data on the NVHO will be automatically uploaded to the Notal Health Cloud and from there the reconstructed volume scans will sent to the study database.

Eligible Conditions
  • Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month following reading center grading completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month following reading center grading completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Negative percent agreement
Percentage of subjects who Successful completed NVHO self-imaging
Percentage of subjects who successfully completed the setup of the NVHO device
+1 more
Secondary outcome measures
Percentage of all sessions that were transmission successfully
Percentage of sessions containing self-imaging that were transmitted successfully

Find a Location

Who is running the clinical trial?

Notal Vision Inc.Lead Sponsor
8 Previous Clinical Trials
20,674 Total Patients Enrolled
Gidi Benyamini, MDStudy DirectorDruyanov 5, Tel Aviv Israel
Jeff S. Heier, MDPrincipal InvestigatorOphthalmic Consultants of Boston
~29 spots leftby Sep 2025