NOT_YET_RECRUITING
A Study to Determine the Safety and Efficacy of NT-501 With MHFM
This study is to determine the long-term levels of CNTF, and the clinical safety and efficacy of the NT-501 implants with the Medica Hollow Fiber Membrane (MHFM) in participants with macular telangiectasia type 2.
Conditions:
🦠 Macular Telangiectasia Type 2
🗓️ Study Start (Actual) 1 April 2025
🗓️ Primary Completion (Estimated) 27 April 2026
✅ Study Completion (Estimated) 24 July 2026
👥 Enrollment (Estimated) 13
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Walnut Creek, California, United States
📍 Grand Rapids, Michigan, United States
📍 Bellaire, Texas, United States

📋 Eligibility Criteria

Description

  • Key Eligibility Criteria:
  • 1. Subjects must have 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 seen clinically or on SD-OCT.
  • 2. Subject must have a break in the ellipsoid zone (EZ) (area of IS/OS loss) as measured by SD-OCT between 0.16 and 2.00 millimeters squared.
  • 3. Subject'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. Subject must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality retinal imaging.
  • 5. Subject must be 21 years or older and less than 80 years of age at screening.
  • 6. Subject or their legally authorized representative 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:

  • 1. Subject is medically unable to comply with study procedures or follow-up visits.
  • 2. Subject received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months.
  • 3. Subject 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. Subject 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., uncontrolled glaucoma, severe non-proliferative or proliferative diabetic retinopathy, uveitis).
  • 5. Subject 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. The exceptions to this exclusion criteria include artificial tears or one glaucoma medication for early or intermediate primary open-angle glaucoma.
  • 6. Subject has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye.
  • 7. Subject has evidence of intraretinal hyperreflectivity by OCT.
  • 8. Subject has evidence of central serous chorio-retinopathy in either eye.
  • 9. Subject has evidence of pathologic myopia in either eye.
  • 10. Subject has significant corneal or media opacities in either eye.
  • 11. Subject has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty.
  • 12. Subject 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.
  • 13. Subject has undergone lens removal in the previous 3 months or YAG laser within 4 weeks.
  • 14. Subject was a participant in any other ocular related or ocular impacted clinical trial of an intervention (drug or device) within the last 6 months.
  • 15. Subject is on chemotherapy.
  • 16. Subject is pregnant or breastfeeding.
  • 17. Subject has a history of malignancy that would compromise the 12-month study survival.
  • 18. Subject with a history of ocular herpes virus in either eye.
  • 19. Subject 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.
  • 20. Subject has evidence of subfoveal RPE hyperplasia.
Ages Eligible for Study: 21 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 April 2024
  • First Submitted that Met QC Criteria 29 April 2024
  • First Posted 2 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 July 2024
  • Last Update Posted 25 July 2024
  • Last Verified July 2024