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:November 24, 2017
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
17
sites
Bethesda, Maryland 20892
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Cleveland, Ohio 44130
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Cleveland, OH
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Colorado Springs, Colorado
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Colorado Springs, CO
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1432 Kimbrough Road
Germantown, Tennessee 38138
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Germantown, TN
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Hagerstown, Maryland 21740
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Hagerstown, MD
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Knoxville, Tennessee 37909
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Knoxville, TN
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3811 Valley Centre Drive
La Jolla, California 92037
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La Jolla, CA
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Los Angeles, CA
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Manhattan, NY
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Metairie, Louisiana 70006
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Metairie, LA
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Palo Alto, California 94303
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Palo Alto, CA
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Perth, Western Australia
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Perth,
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Reno, Nevada 89502
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Reno, NV
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Royal Oak, Michigan 48073
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Royal Oak, MI
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Salt Lake City, UT
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Tulsa, Oklahoma 74133
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Tulsa, OK
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Walnut Creek, California 94598
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Walnut Creek, CA
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