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

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ClinicalTrials.gov Identifier: NCT03319849
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Macular Telangiectasia Type 2 Combination Product: Renexus® Procedure: Sham Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia Type 2
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Renexus® Combination Product: Renexus®
Surgery to receive one Renexus® device implant.

Sham Comparator: Sham Procedure: Sham
Non-penetrating sham procedure to mimic implant procedure.




Primary Outcome Measures :
  1. Mean Change in Ellipsoid Zone (EZ) [ Time Frame: Baseline through 24 months. ]
    Mean change in EZ as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye.


Secondary Outcome Measures :
  1. Central Macular Thickness [ Time Frame: Baseline through 24 months. ]
    Renexus® compared to sham relative to mean change in central macular thickness.

  2. Proportion of Eyes with >35% Increase in EZ Break Area [ Time Frame: From baseline at month 24. ]
    Renexus ® compared to sham relative to proportion of eyes with >35% increase in EZ break area.

  3. Mean Change in Aggregate Sensitivity of Microperimetry [ Time Frame: Baseline through 24 months. ]
    Renexus ® compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.

  4. Mean Change in Reading Speed [ Time Frame: Baseline through 24 months. ]
    Renexus® compared to sham relative to mean change in reading speed assessed using Internal Reading Speed Texts (IReST) cards.

  5. National Eye Institute-Visual Function Questionnaire (NEI-VFQ) [ Time Frame: Baseline through 24 months. ]
    Renexus® compared to sham relative to mean change in the NEI-VFQ near activities subscale score.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319849


Contacts
Contact: Kenneth J. Mandell, MD, PhD 678-427-2334 k.mandell@neurotechusa.com

Locations
United States, Florida
University of Miami-Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Philip J. Rosenfeld, MD, PhD         
United States, Georgia
Emory University Eye Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jiong Yan, MD         
United States, Illinois
Northwestern University, Department of Ophthalmology Recruiting
Chicago, Illinois, United States, 60611
Contact: Amani Fawzi, MD         
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dean Eliott, MD         
New England Retina Consultants Not yet recruiting
Springfield, Massachusetts, United States, 01107
Contact: David Lally, MD         
United States, Michigan
University of Michigan, Kellogg Eye Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Grant M. Comer, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sophie Bakri, MD         
United States, New Jersey
Retina Center of New Jersey, LLC Recruiting
Bloomfield, New Jersey, United States, 07003
Contact: Patrick Higgins, MD         
United States, New York
University of Rochester Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14642
Contact: Mina Chung, MD         
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Daniel Miller, MD, PhD         
United States, Oregon
Retina Northwest, P.C. - Sylvan Recruiting
Portland, Oregon, United States, 97210
Contact: Michael S. Lee, MD         
United States, Pennsylvania
Scheie Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexander Brucker, MD         
United States, Texas
Retina Research Center, PLLC Recruiting
Austin, Texas, United States, 78705
Contact: Brian B. Berger, MD         
Retina Consultants of Houston, PA Recruiting
Houston, Texas, United States, 77030
Contact: Charles C Wykoff, MD, PhD         
Australia, New South Wales
Sydney Eye Hospital Recruiting
Sydney, New South Wales, Australia, 2000
Contact: Mark Gillies         
Australia, Victoria
Royal Victorian Eye and Ear Hospital Research and Ethics Committee Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Robyn Guymer         
Germany
Universitäts Klinikum Bonn Recruiting
Bonn, Germany, 53127
Contact: Frank Holz         
Klinik für Augenheilkunde, Universitätsklinikum Freiburg Augenklinik Retinologie Studien Recruiting
Freiburg, Germany, 79106
Contact: Felicitas Bucher         
St. Franziskus Hospital Recruiting
Münster, Germany, 48145
Contact: Daniel Pauleikhoff         
Sponsors and Collaborators
Neurotech Pharmaceuticals
Investigators
Study Chair: Kenneth J. Mandell, MD, PhD Neurotech Pharmaceuticals, Inc.

Responsible Party: Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03319849     History of Changes
Other Study ID Numbers: NTMT-03-B
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Neurotech Pharmaceuticals:
Ciliary Neurotrophic Factor (CNTF)
Macular Telangiectasia (MacTel)

Additional relevant MeSH terms:
Telangiectasis
Vascular Diseases
Cardiovascular Diseases