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A Phase III Multicenter Randomized, Sham Controlled,Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia type 2 NTMT-03A

Trial ID:
IRB-17-7052
Richard Lin
This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.

Key Inclusion Criteria: - Participant must have at least one study eye with a positive diagnosis of MacTel Type 2 - Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm^2 and 2.00 mm^2 - Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart Key Exclusion Criteria: - Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months - Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye or has, within the past 3 months, received intravitreal anti-VEGF in the fellow eye - Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study - Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months - Participant is pregnant or breastfeeding - Participant has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications

Why isn't this trial accepting new patients?

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