Macular Telangiectasia type 2
Conditions
Interventions
Product Name: Renexus®
Product Code: NT501.6A.02
Pharmaceutical Form: Implant
INN or Proposed INN: Ciliary Neurotrophic factor (CNTF)
Current Sponsor code: NT501.6A.02
Concentration unit: ng nanogram(
Sponsors
Neurotech Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this study, the potential participant and at least one of his or her eyes must meet all of the following criteria: 1. Participant must have at least one study eye with a positive diagnosis of MacTel Type 2 with evidence of fluorescein leakage typical of MacTel or at least one of the other features including retinal opacification, crystalline deposits, right angle vessels, inner/outer lamellar cavities or hyperpigmentation not involving the center of the fovea, but no evidence of intraretinal/subretinal neovascularization and no evidence of retinal pigment epithelial hyperpigmentation. 2. Participant must have an IS/OS PR break and en face ellipsoid zone (area of IS/OS loss) as measured by SD-OCT between 0.16 mm2 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; 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 112
Exclusion criteria
Exclusion criteria: To participate in this study, the potential participant must not meet any of the following 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 for neovascular disease complicating MacTel in either eye; 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, etc.); 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 intra-retinal/sub-retinal neovascularization 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 study 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 is on immunosuppressive therapy; 18.Participant is considered immunodeficient or has a diagnosis of HIV; 19.Participant with a history of ocular Herpes virus in either eye; or 20.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the effect of Renexus® on the mean change from baseline in the ellipsoid zone (area of IS/OS loss) as measured by SD-OCT in eyes with evidence of MacTel Type 2 through 24 months.;Secondary Objective: The secondary objective of this study is to evaluate the safety of Renexus® in patients with MacTel Type 2.;Primary end point(s): The primary outcome will be the mean change in the ellipsoid zone (area of IS/OS loss) from baseline through 24 months as measured by en face imaging by SD-OCT in the study eye.;Timepoint(s) of evaluation of this end point: Baseline, day 1, week 1 and 6, 12, 16, 20, and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Renexus® compared to sham relative to mean change in central macular thickness as measured by SD-OCT from baseline through 24 months Renexus® compared to sham relative proportion of eyes with > 35% increase in EZ break area from baseline at Month 24 only • Renexus ® compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area through 24 months Renexus® compared to sham relative to mean change in reading speed from baseline through 24 months • Renexus® compared to sham relative to mean change in the NEI-VFQ near activities subscale score from baseline through 24 months • Secondary safety endpoint: Persistent deterioration in visual acuity as evidenced by a loss of >15 letters using the ETDRS distance chart;Timepoint(s) of evaluation of this end point: Baseline, day 1, week 1 and 6, 12, 16, 20, and 24 months | — |
Countries
Australia, France, United States
Contacts
Public ContactJenni Bursell
Neurotech Pharmaceuticals
Outcome results
None listed