Status:
COMPLETED
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A
Lead Sponsor:
Neurotech Pharmaceuticals
Collaborating Sponsors:
The Lowy Medical Research Institute Limited
Conditions:
Macular Telangiectasia Type 2 (MacTel)
Eligibility:
All Genders
21-80 years
Phase:
PHASE3
Brief Summary
This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.
Detailed Description
Phase 3, prospective, multicenter, masked, sham-controlled study with the overall study objective to evaluate the efficacy and safety of NT-501 for the treatment of MacTel. Secondary objective was to ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 (SD-OCT) between 0.16 mm\^2 and 2.00 mm\^2
- Participant's best corrected visual acuity (BCVA) is a 54-letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at screening.
- 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 at screening
- 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
- Women of childbearing potential must agree to use highly effective contraception (Germany and France only)
- Key
Exclusion
- Participant is medically unable to comply with study procedures or follow-up visits
- 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 in the study eye OR has, within the past 3 months, received intravitreal anti-VEGF in the fellow eye at randomization
- 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 subretinal neovascularization (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
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03316300
Start Date
November 24 2017
End Date
September 23 2022
Last Update
September 24 2024
Active Locations (20)
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1
Scripps Clinic Medical Group
La Jolla, California, United States, 92037
2
Jules Stein Eye Institute / David Geffen School of Medicine
Los Angeles, California, United States, 90095
3
Byers Eye Institute at Stanford University
Palo Alto, California, United States, 94303
4
Bay Area Retina Associates
Walnut Creek, California, United States, 94598