Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04729972




Registration number
NCT04729972
Ethics application status
Date submitted
25/01/2021
Date registered
29/01/2021
Date last updated
28/05/2024

Titles & IDs
Public title
Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2
Scientific title
Phase II, Multicenter, Open-label Safety Study of Bilateral NT-501 in Participants With Macular Telangiectasia Type 2
Secondary ID [1] 0 0
NTMT-02B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Telangiectasia Type 2 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - NT-501 CNTF implant

Experimental: NT-501 CNTF Implant - Participants from the NTMT-01/02 Extenstion study or participants from the NTMT-03 study which received an implant Studies with a CNFT implant in one eye will receive an implant in the fellow eye


Other interventions: NT-501 CNTF implant
Single implantation of CNTF-secreting NT-501 device into one eye
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ocular and Systemic Safety
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Best correct visual acuity
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2022
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Save Sight Institute - Sydney
Recruitment hospital [2] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [3] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Neurotech Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Lowy Medical Research Institute Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Hohman, PhD
Address 0 0
Neurotech Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Chew EY, Clemons TE, Jaffe GJ, Johnson CA, Farsiu ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT04729972