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  3. Testing a gene therapy to treat wet age-related macular degeneration
Research Study

Phase 1/2a Open-label Study to Evaluate Safety, Tolerability and Preliminary Efficacy of NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration

Principal Investigator
Eduardo Navajas

Overview

Body Locations and Systems
Eyes and Vision
ClinicalTrials.gov#
NCT05984927
Status
Recruiting
Start/End Dates
Mar 1, 2024
Locations
Eye Care Centre
Name/Title
Levina Ira, Research Assistant
Phone
604-875-4111 ext.62178
Email Address
levina.ira@vch.ca
Purpose of Study

The purpose of this study is to investigate NG101 AAV gene therapy in adults with wet age-related macular degeneration. NG101 is being developed as a novel one-time gene therapy for the treatment of wet AMD, a significant cause of vision loss in patients worldwide. Current standard of care therapies require life-long intraocular injections (typically repeated every four to 12 weeks) to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time.

Eligible participants will have outpatient day surgery for administration of NG101 including pre-operative vitreous humor sample collection, followed by safety monitoring which will include blood tests, eye examination, vitreous humor sample collection, eye imaging procedures, physical examination, ECG, adverse events monitoring and questionnaires.

Eligibility

Visit ClinicalTrials.gov for more information.

Disclaimer

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific research studies only. If you have specific questions which require clinical expertise, please call your primary care physician.

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