A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2

Phase 3

Completed

• Conditions: Macular Telangiectasia Type 2
• Interventions: Procedure: Sham; Combination Product: NT-501

• Registration Number: NCT03319849
• Lead Sponsor: Neurotech Pharmaceuticals

Brief Summary

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.

Detailed Description

Phase 3, prospective, multicenter, masked, sham-controlled study with the overall study objective to evaluate the efficacy and safety of NT-501 for the treatment of MacTel. Secondary objective was to evaluate the safety of NT-501 in participants with MacTel. This was a multicenter study conducted at 20 study centers in the United States, Australia, Germany, and the United Kingdom.

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-24
• Study Start: 2018-02-06
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham	A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product.
NT-501	NT-501	Test product

Primary Outcome Measures

Name	Time	Method
The Rate of Change in the Area of EZ Area of Loss From Baseline Through Month 24	End point timeframe is through Month 24. Baseline, Month 6, 12, 16, 20 and 24. Month 6 was collected but not included in the primary analyses.	The rate of change in the area of EZ loss (IS/OS; macular photoreceptor loss) from baseline through month 24, as assessed using SD-OCT in the study eye of participants with MacTel.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population)	Baseline through 24 months.	Change from baseline in retinal sensitivity loss as measured by as measured by Macular Integrity Assessment (MAIA)
Monocular Reading Speed (mITT Population)	Baseline through 24 months.	Change from baseline through Month 24 for Monocular reading speed assessed using International Reading Speed Texts (IReST) cards developed by the IReST Study Group 21

Trial Locations

Locations (27)

The Retina Institute; 🇺🇸 Chesterfield, Missouri, United States

Retina Vitreous Assoc; 🇺🇸 Beverly Hills, California, United States

Northwestern Medical Group; 🇺🇸 Chicago, Illinois, United States

Massachusetts Eye and Ear Infirmary Ophthalmology Clinical Research Office; 🇺🇸 Boston, Massachusetts, United States

Retina Center of New Jersey - Envision Ocular, LLC; 🇺🇸 Bloomfield, New Jersey, United States

Flaum Eye - University of Rochester; 🇺🇸 Rochester, New York, United States

Retina Northwest, PC; 🇺🇸 Portland, Oregon, United States

Scheie Eye Institute - University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Austin Clinical Research, LLC; 🇺🇸 Austin, Texas, United States

Retina Consultants of Texas; 🇺🇸 Bellaire, Texas, United States

Save Sight Institute, Sydney; 🇦🇺 Sydney, New South Wales, Australia

Centre for Eye Research Australia Macular Research Unit; 🇦🇺 East Melbourne, Victoria, Australia

Klinik at Freiberg, Germany; 🇩🇪 Freiburg, Baden-Wurttemberg Germany, Germany

University of Bonn; 🇩🇪 Bonn, NRW, Germany

St. Franziskus, Muenster; 🇩🇪 Muenster, NRW, Germany

Retina Consultants of Southern Colorado, P.C.; 🇺🇸 Colorado Springs, Colorado, United States

Emory University Eye Center; 🇺🇸 Atlanta, Georgia, United States

Elman Retina Group, PA; 🇺🇸 Baltimore, Maryland, United States

New England Retina Consultants; 🇺🇸 Springfield, Massachusetts, United States

University of Michigan, Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Rochester Strong Memorial Hospital; 🇺🇸 Rochester, New York, United States

Cincinnati Eye Institute; 🇺🇸 Cincinnati, Ohio, United States

Tulsa Retina Consultants; 🇺🇸 Tulsa, Oklahoma, United States

Palmetto Retina Center; 🇺🇸 West Columbia, South Carolina, United States

Southeastern Retina Associates, PC; 🇺🇸 Knoxville, Tennessee, United States

Retina Center of Texas; 🇺🇸 Southlake, Texas, United States