NT-501 Implant for Macular Telangiectasia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new implant called NT-501, an encapsulated cell therapy, to determine its effectiveness for macular telangiectasia type 2, a condition affecting vision. The trial aims to assess the implant's efficacy and safety. Suitable participants have been diagnosed with MacTel and experience vision issues such as blurry vision or difficulty reading. The implant is placed in one eye to evaluate its potential to improve vision. Participants should not have received certain other eye treatments recently. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for vision improvement.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you have a chronic requirement for ocular medications, you may be excluded unless it's for artificial tears or one glaucoma medication for early or intermediate primary open-angle glaucoma.
What prior data suggests that the NT-501 implant is safe for treating macular telangiectasia?
Research has shown that the NT-501 CNTF implant is safe and well-tolerated in earlier studies. For instance, in studies involving individuals with macular telangiectasia (a rare eye disease), the NT-501 implant reduced vision loss compared to placebo procedures, demonstrating promise without major side effects. Another study found it safe for patients with primary open-angle glaucoma (a common type of glaucoma), with no significant safety concerns reported.
These findings suggest that the NT-501 implant is generally well-tolerated. As this is a Phase 3 trial, the treatment has already undergone testing for safety and effectiveness, but it is still being studied to confirm its efficacy in a larger group. Prospective participants should find these results encouraging, but discussing any concerns with the study team is advisable.12345Why do researchers think this study treatment might be promising for macular telangiectasia?
Unlike the standard treatments for Macular Telangiectasia, which often include eye injections or laser therapy, the NT-501 implant offers a unique approach. This implant continuously releases ciliary neurotrophic factor (CNTF) directly into the eye, providing long-term treatment without the need for frequent doctor visits. Researchers are excited because this delivery method could potentially offer sustained benefits and protect the retina over time, which might result in better vision preservation for patients.
What evidence suggests that the NT-501 implant is effective for macular telangiectasia?
Studies have shown that the NT-501 implant effectively treats macular telangiectasia type 2. Research indicates that it can slow retinal damage and significantly reduce the loss of certain eye parts compared to no treatment. Specifically, previous patients demonstrated both structural and functional improvements in their eyes after receiving the implant. The treatment is considered safe and well-tolerated, with promising results in maintaining eye health. This therapy delivers a substance called ciliary neurotrophic factor, which helps protect nerve cells in the eye. Participants in this trial will receive the NT-501 CNTF implant in one eye using the Medica Hollow Fiber Membrane (MHFM).12467
Who Is on the Research Team?
Thomas Aaberg, Jr., MD
Principal Investigator
Neurotech Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for individuals with a condition affecting the blood vessels in their eyes, known as macular telangiectasia type 2. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have a particular stage or severity of the condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the NT-501 CNTF implant in one eye using the Medica Hollow Fiber Membrane (MHFM)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NT-501
NT-501 is already approved in United States for the following indications:
- Glaucoma
- Retinitis pigmentosa
- Age-related macular degeneration
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurotech Pharmaceuticals
Lead Sponsor