Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Retina
Enrollment Eligibility
General Inclusion Criteria
1. Participants from the NTMT-03 study must have completed the Month-24 visit
2. 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)
3. Participant must be willing and able to follow the study instructions and be willing
and able to complete all required study procedures and visits
4. 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
5. Females of childbearing potential must consent to a pregnancy test before entering the
study
6. 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
Ocular Inclusion Criteria
1. 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
2. Participant must have steady fixation in the foveal or parafoveal area in the study
eye and sufficiently clear media for good quality photographs
General Exclusion Criteria
1. 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:
- Pregnant (positive pregnancy test at Visit 1 or intend to become pregnant during
the study)
- Nursing (lactating)
- Do not agree to use adequate birth control methods for the duration of the study
and until 90 days after the last administration of study drug (adequate birth
control methods are: hormonal - oral, implantable, transdermal or injectable
contraceptives; mechanical - spermicide in conjunction with a barrier such as
condom or diaphragm, intrauterine device [IUD] or surgical sterilization of
partner, or total sexual abstinence)
2. Participant is too ill to likely complete the entire study, based on the
investigator's assessment
3. Participant, in the opinion of the investigator, is not suitable for study
participation
4. Participant with any screening laboratory finding (serum chemistry, hematology,
urinalysis) that in the opinion of the investigator is not suitable for study
participation
5. Participant has a history or current evidence of severe hypersensitivity to the NT-501
implant
6. 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
Ocular Exclusion Criteria
1. Participant has a history or evidence of the following surgeries/procedures in the
study eye, as assessed at Visit 1, including:
- Submacular surgery
- Vitrectomy
- Retinal detachment
- Incisional glaucoma surgery
- Trabeculectomy or trabeculoplasty
- Cataract surgery or laser-assisted in situ keratomileusis (LASIK) performed in
the previous 6 months
2. Participant has uncontrolled glaucoma; or ocular hypertension, i.e., IOP ≥ 25 mmHg in
the study eye
3. Participant has evidence of intraretinal or subretinal neovascularization or central
serous chorioretinopathy in the study eye
4. Participant has evidence of ocular disorder(s) in the study eye of a severity that
could confound the interpretation of study results, compromise visual acuity or
require medical or surgical intervention during the study period, including retinal
vascular occlusion, severe nonproliferative or proliferative diabetic retinopathy,
retinal detachment, macular hole, geographic atrophy, intraretinal or subretinal
neovascularization, central serous chorio-retinopathy, pathological myopia
5. Participant has a vitreous hemorrhage in the study eye at Visit 1 (Screening)
6. Participant has a spherical equivalent of the refractive error in the study eye
demonstrating more than 8 diopters of myopia
7. Participant has a history or evidence of penetrating ocular trauma in the study eye
8. Participant has an anticipated need for cataract extraction in the study eye within 6
months of Visit 1 (Screening) such as 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
9. Participant has uveitis, history of uveitis in either eye or history of ocular herpes
virus in either eye
10. Participant has undergone major surgery within the last 6 months (systemic or ocular
in either eye) or who are likely to require major surgery within 6 months of Visit 1
(Screening)
11. Participant has periocular or ocular/intraocular infection or inflammation in either
eye (such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis) within
3 months prior to Visit 1 (Screening)
12. Participant has ocular hypotension in either eye (<6 mmHg) that in the opinion of the
Investigator would interfere with the NT-501 implant insertion
13. Participant has a history of scleritis, scleral thinning, periocular, ocular, or
intraocular infection or inflammation, cicatrizing conjunctival diseases any other
ocular conditions in the study eye that could interfere with or complicate the surgery
associated with NT-501implant insertion