Study to Determine the Safety and Effectiveness of Treating Macular Tetangiectasia Type 2 Patients with Renexus

Overview

About this study

The purose of this study is to determine the safety and effectiveness of treating macular tetangiectasia type 2 patients with Renexus.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Participant must have at least 1 study eye with a positive diagnosis of MacTel with evidence of fluorescein leakage typical of MacTel and at least one of the other features that include hyperpigmentation that is outside of a 500 micron
  • radius from the center of the fovea, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities
  • Participant must have an IS/OS PR break and EZ (area of IS/OS loss) as measured by SD-OCT between 0.16 and 2.00 mm2
  • Participant’s best-corrected visual acuity (BCVA) is 54-letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
  • Participant must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality photographs
  • Participant must be greater than 21 years of age or less than 80 years of age
  • Participant must be able to provide written informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practices guidelines, and local regulations, before initiating  any study-related procedures

Exclusion Criteria:

  • Participant is medically unable to comply with study procedures or follow-up visits
  • Participant received intravitreal steroid therapy for nonneovascular 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 therapy 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 (eg, glaucoma, severe nonproliferative or proliferative diabetic retinopathy, uveitis)
  • Participant has a chronic requirement (eg, ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease that, in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted)
  • Participant has evidence of intraretinal neovascularization or SRNV, as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye
  • Participant has evidence of central serous chorio-retinopathy in either eye
  • Participant has evidence of pathologic myopia in either eye 
  • Participant has significant corneal or media opacities in either eye
  • Participant has had a vitrectomy, penetrating keratoplasty,
  • trabeculectomy, or trabeculoplasty
  • Participant has any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or a nuclear opacity > standard 3 as measured on the Age-Related Eye Disease Study (AREDS) clinical lens grading system
  • Participant has undergone lens removal in the previous 3 months or YAG laser within 4 weeks
  • Participant was a participant in any other clinical trial of an intervention (drug or device) within the last 6 months
  • Participant is on chemotherapy
  • Participant is pregnant or breastfeeding
  • Participant has a history of malignancy that would compromise the 24-month study survival
  • Participant with a history of ocular herpes virus in either eye 
  • Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments
  • Participant has evidence of intraretinal hyperreflectivity by OCT

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sophie Bakri, M.D.

Open for enrollment

Contact information:

Heidi Rubin CCRP

(507) 538-8119

rubin.heidi@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available