Principal Investigator: Paul Bernstein
Keywords: Eye disease , Retina , Treatment trial Department: Ophthalmology-Services
IRB Number: 00105598
Specialty: Ophthalmology
Sub Specialties: Retinal Diseases
Recruitment Status: Recruiting

Contact Information

Kara Halsey

Simple Summary

To determine if the Renexus intraocular implant benefits visual function in patients with Macular Telangiectasia type 2

Inclusion Criteria

1. Participant must have at least one 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;

2. Participant must have an IS/OS PR break and ellipsoid zone (area of IS/OS loss) as measured by SD-OCT between 0.16 and 2.00 mm2;

3. Participant’s best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the ETDRS chart at screening;

4. Participant must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality photographs;

5. Participant must be greater than 21 years of age or less than 80 years of age at screening

6. Participant must be able to provide a written informed consent to participate in the study, in accordance with the ICH GCP guidelines, and local regulations, before initiating any study related procedures.

Exclusion Criteria

The ocular exclusion criteria are related to the study eye (unless indicated for either eye):

1. Participant is medically unable to comply with study procedures or follow-up visits;

2. Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months;

3. Participant has ever received intravitreal anti-VEGF therapy in the study eye OR has, within the past 3 months, received intravitreal anti-VEGF therapy in the fellow eye at randomization;

4. 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 (e.g., glaucoma, severe non-proliferative or proliferative diabetic retinopathy, uveitis);

5. Participant has a chronic requirement (e.g., ≥ 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);

6. Participant has evidence of intraretinal neovascularization or SRNV, as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye;

7. Participant has evidence of central serous chorio-retinopathy (CSCR) in either eye;

8. Participant has evidence of pathologic myopia in either eye;

9. Participant has significant corneal or media opacities in either eye;

10. Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty;

11. 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 AREDS clinical lens grading system;

12. Participant has undergone lens removal in the previous 3 months or YAG laser within 4 weeks;

13. Participant was a participant in any other clinical trial of an intervention (drug or device) within the last 6 months;

14. Participant is on chemotherapy;

15. Participant is pregnant or breastfeeding;

16. Participant has a history of malignancy that would compromise the 24-month study survival;

17. Participant with a history of ocular Herpes virus in either eye; 

18. 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

19.  Participant has evidence of intraretinal hyperreflectivity by OCT.

Participant Reimbursement

Participants receive $75 for completion of each required visit up to a maximum of $675 for study completion. Participants may also be eligible for additional assistance with travel expenses.