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

Use our guide to learn which trials are right for you!

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
Cleveland, Ohio 44130
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Colorado Springs, Colorado
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
1432 Kimbrough Road
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Hagerstown, Maryland 21740
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
Knoxville, Tennessee 37909
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
3811 Valley Centre Drive
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Manhattan, NY
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Palo Alto, California 94303
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Perth, Western Australia
?
mi
from
Perth,
Click here to add this to my saved trials
Reno, Nevada 89502
?
mi
from
Reno, NV
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Tulsa, Oklahoma 74133
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Walnut Creek, California 94598
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials