CompletedPhase 2

Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2

United States33 participantsStarted 2021-07-21

Plain-language summary

This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF implants in participants with Macular Telangiectasia Type 2.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants from the NTMT-03 study must have completed the Month-24 visit
✓. Participant in the MacTel Phase 1/2 extension (NTMT-01/02E) study or the Phase 3 study must exit these studies prior to entering the Bilateral Implant safety study (NTMT-02B)
✓. Participant must be willing and able to follow the study instructions and be willing and able to complete all required study procedures and visits
✓. Participant must be willing and able to provide a signed Informed Consent, as well as written documentation in accordance with the relevant country and local privacy requirements, e.g., written data protection consent
✓. Females of childbearing potential must consent to a pregnancy test before entering the study
✓. A participant's refusal to allow the collection of blood samples for analysis of serum CNTF, serum Ab or Nab to CNTF, Ab to NTC-201.6A cells and Ab to DFHR levels in one eye will not exclude the participant from study participation
✓. Participant must have a positive diagnosis of MacTel type 2 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 in the study eye
✓. Participant must have steady fixation in the foveal or parafoveal area in the study eye and sufficiently clear media for good quality photographs

Exclusion criteria

✕. Females of childbearing potential (those who are not surgically sterilized or post- menopausal, i.e., absence of menstruation for 12 months or longer) may not participate in the study if any of the following conditions exists:
✕. Participant is too ill to likely complete the entire study, based on the investigator's assessment
✕. Participant, in the opinion of the investigator, is not suitable for study participation
✕. Participant with any screening laboratory finding (serum chemistry, hematology, urinalysis) that in the opinion of the investigator is not suitable for study participation
✕. Participant has a history or current evidence of severe hypersensitivity to the NT-501 implant
✕. Participant has a history or current evidence of a medical condition (systemic or ophthalmic disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that may in the opinion of the investigator preclude the safe administration of the NT-501 implant or adherence to the scheduled study visits, safe participation in the study or affect the results of the study (e.g., unstable or progressive cardiovascular, cerebral vascular, pulmonary, Parkinson's, liver or renal disease; depression, cancer, or dementia
✕. Participant has a history or evidence of the following surgeries/procedures in the study eye, as assessed at Visit 1, including:
✕. Participant has uncontrolled glaucoma; or ocular hypertension, i.e., IOP ≥ 25 mmHg in the study eye

What they're measuring

Frequency of Ocular and/or Non-ocular Treatment Emergent Adverse Events

Timeframe: 6 months

Trial details

NCT IDNCT04729972

SponsorNeurotech Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-08

Results submitted2024-07-24

View on ClinicalTrials.gov More Macular Telangiectasia Type 2 trials