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MacTel - Renexus Implant

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

Study Description:

Condition or DiseaseIntervention / Treatment PhaseSponsor Status 
 Macular Telangiectasia Type 2 Combination Product: Renexus
Procedure: Sheam
 Neurotech Enrolling

 

 

 

Purpose: 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.

Inclusion Criteria:

  • Ages Eligible for Study - 21 to 80.
  • Sexes Eligible for Study - All.
  • 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.

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 for neovascular disease complicating MacTel in either 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.

Contact:  Beachwood Office  Diane Weiss  •  dew@retina-assoc.com.

For more information https://clinicaltrials.gov/ct2/show/NCT03316300