A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
- Conditions
- Macular Telangiectasia Type 2
- Interventions
- Procedure: ShamCombination 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- 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
- 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
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