Macular Telangiectasia Type 2Phase 2NCT01949324
A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel
A Phase 2 study testing Ciliary neurotrophic factor (CNTF), NT-501 Implant and NT-501 Implant procedure in people with Macular Telangiectasia Type 2, run by Neurotech Pharmaceuticals at 11 sites in 2 countries.
Trial summary
This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Macular Telangiectasia Type 2
- What is being tested?
- Ciliary neurotrophic factor (CNTF), NT-501 Implant and NT-501 Implant procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Apr 2014to 22 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent
- Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
- Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone (area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2
- If female, participant must be incapable of pregnancy
- If male, participant must agree to use an effective form of birth control during the study
Who cannot join
- Participant is unable to provide informed consent
- Participant is less than 21 years of age or greater than 80 years of age
- Participant is medically unable to comply with study procedures or follow-up visits
- Participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months
- Participant is pregnant or breastfeeding
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, 48105
Emory University
Atlanta, Georgia, 30322
Retina Associates of Cleveland, Inc.
Beachwood, Ohio, 44122
National Eye Institute
Bethesda, Maryland, 20892
Massachusetts Eye and Ear Infirmary, Retina Service
Boston, Massachusetts, 02114
Jules Stein Eye Institute
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53705
Bascom Palmer
Miami, Florida, 33136
Australia3 sites
Centre for Eye Research Australia
East Melbourne
Lions Eye Institute
Nedlands
Save Sight Institute
Sydney, New South Wales
About this study
Official title: A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)
This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.
- Conditions
- Macular Telangiectasia Type 2
- Being tested
- Ciliary neurotrophic factor (CNTF), Sham procedure, NT-501 Implant, NT-501 Implant procedure
- Keywords
- MacTel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciliary neurotrophic factor (CNTF)Biological
Ciliary neurotrophic factor released from NT-501 encapsulated cell implant
Sham procedureProcedure or surgery
Sham surgery for Sham arm
NT-501 ImplantDevice
NT-501 encapsulated cell implant
NT-501 Implant procedureProcedure or surgery
Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm
| Study group | Role | What they receive |
|---|---|---|
| NT-501 Implant procedure | Experimental | The investigational product is the NT-501 encapsulated cell system which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that were derived from the NTC-200 cell line by genetic modification so as to secrete recombinant human ciliary neurotrophic factor (CNTF). Receives: Biological: Ciliary neurotrophic factor (CNTF); Device: NT-501 Implant; Procedure: NT-501 Implant procedure |
| Sham procedure | Sham comparator | Non-penetrating sham procedure to mimic implant procedure Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)
Change in the ellipsoid zone (area of IS/OS loss) from baseline to month 24 as measured by en face imaging by SDOCT in study eye(s)
Measured: 24 months
Secondary outcomes (7)
Ellipsoid zone
Change in the ellipsoid zone from baseline to Month 12.
Measured: 12 months
Retinal sensitivity (dB) as measured by microperimetry
Change in retinal sensitivity (dB) as measured by microperimetry from baseline to Months 12 and 24.
Measured: 12 and 24 months
Increase in ellipsoid zone
Proportion of study eyes with a 35% or more increase from baseline in the ellipsoid zone at Months 12 and 24.
Measured: 12 and 24 months
Visual Acuity
Change in best corrected visual acuity (BCVA) from baseline to Months 12 and 24.
Measured: 12 and 24 months
Visual Acuity
Proportion of study eyes with 15 or more letter loss from baseline in BCVA at Months 12 and 24.
Measured: 12 and 24 Months
Visual Acuity
Proportion of study eyes with 10 or more letter loss from baseline in BCVA at Months 12 and 24.
Measured: 12 and 24 Months
Reading Speed
Change in reading speed as measured by the IReST from baseline to Months 12 and 24.
Measured: 12 and 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startApr 2014
- Primary completion14 Apr 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular Telangiectasia Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurotech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Lowy Medical Research Institute Limited, The Emmes Company, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949324
- Sponsor's protocol ID
- NTMT-02
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2013
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Loo J, Cai CX, Choong J, Chew EY, Friedlander M, Jaffe GJ, Farsiu S. Deep learning-based classification and segmentation of retinal cavitations on optical coherence tomography images of macular telangiectasia type 2. Br J Ophthalmol. 2022 Mar;106(3):396-402. doi: 10.1136/bjophthalmol-2020-317131. Epub 2020 Nov 23.
PubMed 33229343
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)
- ClinicalTrials.gov ID
- NCT01949324
- Acronym / sponsor ID
- NTMT-02
- Conditions
- Macular Telangiectasia Type 2
- Keywords
- MacTel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Neurotech PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- The Lowy Medical Research Institute Limited, The Emmes Company, LLC
- Study start
- Apr 2014
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT-501 Implant procedure | Experimental | Biological: Ciliary neurotrophic factor (CNTF), Device: NT-501 Implant, Procedure: NT-501 Implant procedureThe investigational product is the NT-501 encapsulated cell system which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that were derived from the NTC-200 cell line by genetic modification so as to secrete recombinant human ciliary neurotrophic factor (CNTF). |
| Sham procedure | Sham comparator | Procedure: Sham procedureNon-penetrating sham procedure to mimic implant procedure |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent
- Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
- Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone (area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2
- If female, participant must be incapable of pregnancy
- If male, participant must agree to use an effective form of birth control during the study
Key exclusion criteria (5 listed)
- Participant is unable to provide informed consent
- Participant is less than 21 years of age or greater than 80 years of age
- Participant is medically unable to comply with study procedures or follow-up visits
- Participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months
- Participant is pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciliary neurotrophic factor (CNTF)Ciliary neurotrophic factor released from NT-501 encapsulated cell implant | Biological | NT-501 Implant procedure |
| Sham procedureSham surgery for Sham arm | Procedure or surgery | Sham procedure |
| NT-501 ImplantNT-501 encapsulated cell implant | Device | NT-501 Implant procedure |
| NT-501 Implant procedureSurgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm | Procedure or surgery | NT-501 Implant procedure |
Primary outcome
Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)
Time frame: 24 months
Change in the ellipsoid zone (area of IS/OS loss) from baseline to month 24 as measured by en face imaging by SDOCT in study eye(s)
7 secondary outcomes
Ellipsoid zone
Time frame: 12 months
Retinal sensitivity (dB) as measured by microperimetry
Time frame: 12 and 24 months
Increase in ellipsoid zone
Time frame: 12 and 24 months
Visual Acuity
Time frame: 12 and 24 months
Visual Acuity
Time frame: 12 and 24 Months
Visual Acuity
Time frame: 12 and 24 Months
Reading Speed
Time frame: 12 and 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Derived from this study: PubMed 33229343Loo J, Cai CX, Choong J, Chew EY, Friedlander M, Jaffe GJ, Farsiu S. Deep learning-based classification and segmentation of retinal cavitations on optical coherence tomography images of macular telangiectasia type 2. Br J Ophthalmol. 2022 Mar;106(3):396-402. doi: 10.1136/bjophthalmol-2020-317131. Epub 2020 Nov 23.
Related trials for Macular Telangiectasia Type 2
Active, not recruitingPhase 3
A Study to Determine the Safety and Efficacy of NT-501 With MHFM
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RecruitingPhase 4
Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants
Macular Telangiectasia Type 2 (MacTel)
Not yet recruitingPhase 3
Study of Serine Supplementation to Protect Vision in MacTel
Macular Telangiectasia Type 2 (MacTel)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciliary neurotrophic factor (CNTF), NT-501 Implant and NT-501 Implant procedure in people with Macular Telangiectasia Type 2, run by Neurotech Pharmaceuticals at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01949324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.