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 |
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.
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
3811 Valley Centre Drive
La Jolla, California 92037
La Jolla, California 92037
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