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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 80
Updated:3/24/2019
Start Date:February 6, 2018
End Date:March 31, 2021
Contact:Kenneth J. Mandell, MD, PhD
Email:k.mandell@neurotechusa.com
Phone:678-427-2334

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

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.


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
We found this trial at
16
sites
Atlanta, Georgia 30322
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Ann Arbor, Michigan 48105
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Ann Arbor, MI
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Austin, Texas 78705
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Austin, TX
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Baltimore, Maryland 21237
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Baltimore, MD
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Bloomfield, New Jersey 07003
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Bloomfield, NJ
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243 Charles St
Boston, Massachusetts 02114
(617) 523-7900
Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...
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Boston, MA
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Chicago, IL
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Cincinnati, Ohio 45242
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Cincinnati, OH
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Houston, Texas 77030
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Houston, TX
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Portland, Oregon 97210
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Portland, OR
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Rochester, Minnesota 55905
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Rochester, MN
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Rochester, NY
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3640 Main Street
Springfield, Massachusetts 01107
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Springfield, MA
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8 Macquarie Street
Sydney, New South Wales 2000
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Sydney,
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