ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03316300
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : December 10, 2018
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 : November 24, 2017
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 International 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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): NCT03316300


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

Locations
United States, California
Scripps Clinic Carmel Valley Ambulatory Surgery Center Recruiting
La Jolla, California, United States, 92037
Contact: Richard Lin, MD         
Jules Stein Eye Institute / David Geffen School of Medicine Recruiting
Los Angeles, California, United States, 90095
Contact: Jean-Pierre Hubschman, MD         
Bay Area Retina Associates Recruiting
Walnut Creek, California, United States, 94598
Contact: Roger Goldberg         
United States, Colorado
Retina Consultants of Southern Colorado, P.C. Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Ryan Rich, MD         
United States, Louisiana
Retina Associates of New Orleans Recruiting
Metairie, Louisiana, United States, 70006
Contact: Stanislav Zhuk, MD         
United States, Maryland
National Institute of Health Recruiting
Bethesda, Maryland, United States, 20892
Contact: Henry Wiley, MD         
Cumberland Valley Retina Consultants Recruiting
Hagerstown, Maryland, United States, 21740
Contact: David J Warrow, MD         
United States, Michigan
Associated Retinal Consultants, P.C. Not yet recruiting
Royal Oak, Michigan, United States, 48073
Contact: Antonio Capone Jr., MD         
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
Contact: Arshad Khanani, MD         
United States, New York
Vitreous Retina Macula Consultants of New York Recruiting
Manhattan, New York, United States, 10022
Contact: Michael Engelbert, MD, PhD         
United States, Ohio
Retina Associates of Cleveland, Inc. Recruiting
Cleveland, Ohio, United States, 44122
Contact: Lawrence J. Singerman, MD         
United States, Tennessee
Southeastern Retina Associates, PC Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Joseph M. Googe, Jr., MD         
United States, Utah
University of Utah John A. Moran Eye Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Paul S. Bernstein, MD, PhD         
Australia, Western Australia
Lions Eye Institute Recruiting
Perth, Western Australia, Australia, 6009
Contact: Ian Constable, MD         
United Kingdom
Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Peter Charbel Issa         
Moorfields Eye Hospital Recruiting
London, United Kingdom, EC1V 2PD
Contact: Catherine Egan         
Sponsors and Collaborators
Neurotech Pharmaceuticals
Investigators
Study Chair: Kenneth J. Mandell, MD, PhD Neurotech Pharmaceuticals, Inc.

Responsible Party: Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03316300     History of Changes
Other Study ID Numbers: NTMT-03-A
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

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