A Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia Type 2

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

Sponsors

Lead Sponsor: Neurotech Pharmaceuticals

Source Neurotech Pharmaceuticals
Brief Summary

This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the Renexus® implants in participants with macular telangiectasia type 2.

Overall Status Active, not recruiting
Start Date February 6, 2018
Completion Date August 31, 2022
Primary Completion Date August 31, 2022
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of Change in Ellipsoid Zone (EZ) Area Loss Baseline through 24 months.
Secondary Outcome
Measure Time Frame
Mean Change in Aggregate Sensitivity of Microperimetry Baseline through 24 months.
Mean Change in Reading Speed Baseline through 24 months.
National Eye Institute-Visual Function Questionnaire (NEI-VFQ) Baseline through 24 months.
Number of Participants with Loss of Best-Corrected Visual Acitivty (BCVA) Baseline through 24 months.
Proportion of Participants with Loss of Best-Corrected Visual Acitivty (BCVA) Baseline through 24 months.
Number of Participants with Treatment-Emergent Serious Adverse Event (SAE) Baseline through 24 months.
Proportion of Participants with Treatment-Emergent Serious Adverse Event (SAE) Baseline through 24 months.
Enrollment 112
Condition
Intervention

Intervention Type: Combination Product

Intervention Name: Renexus®

Description: Surgery to receive one Renexus® device implant.

Arm Group Label: Renexus®

Intervention Type: Procedure

Intervention Name: Sham

Description: Non-penetrating sham procedure to mimic implant procedure.

Arm Group Label: Sham

Eligibility

Criteria:

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

Gender: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Emily Chew, MD Principal Investigator National Eye Institute (NEI)
Location
Facility:
Retina-Vitreous Associates Medical Group | Beverly Hills, California, 90211, United States
Retina Consultants of Southern Colorado, P.C. | Colorado Springs, Colorado, 80909, United States
Emory University Eye Center | Atlanta, Georgia, 30322, United States
Northwestern University, Department of Ophthalmology | Chicago, Illinois, 60611, United States
Elman Retina Group, PA | Baltimore, Maryland, 21237, United States
Massachusetts Eye and Ear Infirmary | Boston, Massachusetts, 02114, United States
New England Retina Consultants | Springfield, Massachusetts, 01107, United States
University of Michigan, Kellogg Eye Center | Ann Arbor, Michigan, 48105, United States
Mayo Clinic | Rochester, Minnesota, 55905, United States
The Retina Institute | Chesterfield, Missouri, 63017, United States
Ophthalmic Consultants of Long Island | Lynbrook, New York, 11563, United States
University of Rochester Strong Memorial Hospital | Rochester, New York, 14642, United States
Cincinnati Eye Institute | Cincinnati, Ohio, 45242, United States
Retina Associates of Cleveland, Inc | Cleveland, Ohio, 44122, United States
Tulsa Retina Consultants | Tulsa, Oklahoma, 74114, United States
Retina Northwest, P.C. - Sylvan | Portland, Oregon, 97210, United States
University of Pennsylvania, Department of Ophthalmology, Scheie Eye Institute | Philadelphia, Pennsylvania, 19104, United States
Palmetto Retina Center | West Columbia, South Carolina, 29169, United States
Southeastern Retina Associates, PC | Knoxville, Tennessee, 37922, United States
Retina Research Institute of Texas | Abilene, Texas, 79606, United States
Retina Research Center, PLLC | Austin, Texas, 78705, United States
Retina Center of Texas | Grapevine, Texas, 76051, United States
Retina Consultants of Houston, PA | Houston, Texas, 77030, United States
Sydney Eye Hospital | Sydney, New South Wales, 2000, Australia
Royal Victorian Eye and Ear Hospital Research and Ethics Committee | East Melbourne, Victoria, 3002, Australia
Universitäts Klinikum Bonn | Bonn, 53127, Germany
Klinik für Augenheilkunde, Universitätsklinikum Freiburg Augenklinik Retinologie Studien | Freiburg, 79106, Germany
St. Franziskus Hospital | Münster, 48145, Germany
Location Countries

Australia

Germany

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Renexus®

Type: Experimental

Label: Sham

Type: Sham Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov