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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03316300




Registration number
NCT03316300
Ethics application status
Date submitted
3/10/2017
Date registered
19/10/2017
Date last updated
5/02/2019

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

Experimental: Renexus -

Sham Comparator: Sham -


Combination Product: Renexus®
Surgery to receive one Renexus® 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
Mean Change in Ellipsoid Zone (EZ) - Mean change in EZ as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye.
Timepoint [1] 0 0
Baseline through 24 months.
Secondary outcome [1] 0 0
Central Macular Thickness - Renexus® compared to sham relative to mean change in central macular thickness.
Timepoint [1] 0 0
Baseline through 24 months.
Secondary outcome [2] 0 0
Proportion of Eyes with >35% Increase in EZ Break Area - Renexus® compared to sham relative to proportion of eyes with > 35% increase in EZ break area.
Timepoint [2] 0 0
From baseline at month 24.
Secondary outcome [3] 0 0
Mean Change in Aggregate Sensitivity of Microperimetry - Renexus ® compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.
Timepoint [3] 0 0
Baseline through 24 months.
Secondary outcome [4] 0 0
Mean Change in Reading Speed - Renexus® compared to sham relative to mean change in reading speed assessed using International Reading Speed Texts (IReST) cards.
Timepoint [4] 0 0
Baseline through 24 months.
Secondary outcome [5] 0 0
National Eye Institute-Visual Function Questionnaire (NEI-VFQ) - Renexus® compared to sham relative to mean change in the NEI-VFQ near activities subscale score.
Timepoint [5] 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Lions Eye Institute - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
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
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
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
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Oxfordshire
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London

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 Renexus® implants in participants with macular telangiectasia type 2.
Trial website
https://clinicaltrials.gov/show/NCT03316300
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kenneth J. Mandell, MD, PhD
Address 0 0
Neurotech Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kenneth J. Mandell, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
678-427-2334
Fax 0 0
Email 0 0
k.mandell@neurotechusa.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable