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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03319849




Registration number
NCT03319849
Ethics application status
Date submitted
3/10/2017
Date registered
24/10/2017
Date last updated
8/02/2023

Titles & IDs
Public title
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
Scientific title
A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
Secondary ID [1] 0 0
NTMT-03-B
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
Combination Product - NT-501
Treatment: Surgery - Sham

Experimental: NT-501 -

Sham Comparator: Sham -


Combination Product: NT-501
Surgery to receive one NT-501 device implant.

Treatment: Surgery: Sham
Non-penetrating sham procedure to mimic implant procedure.
Intervention code [1] 0 0
Combination Product
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Change in Ellipsoid Zone (EZ) Area Loss
Timepoint [1] 0 0
Baseline through 24 months.
Secondary outcome [1] 0 0
Mean Change in Aggregate Sensitivity of Microperimetry
Timepoint [1] 0 0
Baseline through 24 months.
Secondary outcome [2] 0 0
Mean Change in Reading Speed
Timepoint [2] 0 0
Baseline through 24 months.
Secondary outcome [3] 0 0
National Eye Institute-Visual Function Questionnaire (NEI-VFQ)
Timepoint [3] 0 0
Baseline through 24 months.

Eligibility
Key inclusion criteria
Key

- Participant must have at least one study eye with a positive diagnosis of MacTel Type
2

- Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo
Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as
measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm^2 and
2.00 mm^2

- Participant's best corrected visual acuity is 54 letter score or better (20/80 or
better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Key
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant received intravitreal steroid therapy for non-neovascular MacTel within
the last 3 months

- Participant 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 in the fellow eye

- Participant 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

- Participant was a study participant in any other clinical trial of an intervention
(drug or device) within the last 6 months

- Participant is pregnant or breastfeeding

- Participant has a chronic requirement (eg = 4 weeks at a time) for ocular medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
6/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/09/2022
Sample size
Target
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Victorian Eye and Ear Hospital Research and Ethics Committee - East Melbourne
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Germany
State/province [18] 0 0
Bonn
Country [19] 0 0
Germany
State/province [19] 0 0
Freiburg
Country [20] 0 0
Germany
State/province [20] 0 0
Münster

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Neurotech Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety
of the NT-501 implants in participants with macular telangiectasia type 2.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03319849
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emily Chew, MD
Address 0 0
National Eye Institute (NEI)
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03319849