Macular Telangiectasia type 2
Conditions
Interventions
Product Name: Renexus implant
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
Sponsors
Neurotech Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this study, the potential participant and at least 1 of their eyes must meet all of the following criteria: 1. 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 2. 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 3. 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 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 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 7. Women of childbearing potential must agree to use highly effective contraception (Germany and France only) 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-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 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 (eg, glaucoma, severe nonproliferative or proliferative diabetic retinopathy, uveitis) 5. 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) 6. Participant has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye 7. Participant has evidence of central serous chorio-retinopathy 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 Age Related Eye Disease Study (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this study is to evaluate the efficacy and safety of Renexus for the treatment of MacTel. Primary objective: • To determine the rate of change in the EZ (IS/OS) area loss over 24 months, as measured by study eye SD-OCT in participants with MacTel ;Secondary Objective: The secondary objective of this study is to evaluate the safety of Renexus® in participants with MacTel ;Primary end point(s): The rate of change in the EZ (IS/OS) area loss over 24 months, as measured by study eye SD-OCT in participants with MacTel;Timepoint(s) of evaluation of this end point: Baseline, Day 1, Week 1 and 1, 3, 6, 12, 16, 20 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean change in aggregate sensitivity of microperimetry within the EZ line break area through 24 months • Mean change in reading speed from baseline through 24 months • Mean change in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) near activities subscale score from baseline through 24 months ;Timepoint(s) of evaluation of this end point: Baseline, Day 1, Week 1 and 1,3, 6, 12, 16, 20 and 24 months. | — |
Countries
Australia, France, Germany, United Kingdom, United States
Contacts
Public ContactJenni Bursell
Neurotech Pharmaceuticals
Outcome results
None listed