Idiopathic Juxtafoveal TelangiectasiaPhase 1NCT01327911

Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)

A Phase 1 study testing NT-501 implant in people with Idiopathic Juxtafoveal Telangiectasia, run by Neurotech Pharmaceuticals at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Idiopathic Juxtafoveal Telangiectasia
What is being tested?: NT-501 implant
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 2 sitesUnited States
Study dates: May 2011to Sep 2016
Phase: Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The participant must be offered sufficient opportunity to review the informed consent form, agree to the form's contents and sign the protocol's informed consent;
The participant must have bilateral MacTel;
Women of childbearing potential and all men must agree to use an effective form of birth control during the study;
Participant must be medically able to undergo ophthalmic surgery for ECT implant;
The participant's best-corrected visual acuity 64 letters or better (20/50 or better) in the study eye;

Who cannot join

Participant is < 21 years of age;
Participant is medically unable to comply with study procedures or follow- up visits;
Participant has evidence of ocular disease other than MacTel that may confound the outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis, etc.);
Participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease, that in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted);
Participant has evidence of subretinal neovascularization in either eye;
Participant has evidence of central serous chorio-retinopathy (CSR) in either eye;
Participant has evidence of pathologic myopia in either eye;
Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty;

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Retina Associates of Cleveland
Cleveland, Ohio, 44122
Jules Stein Eye Institute
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)

This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.

Read the detailed description

Protocol for Extended Follow-up of a Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel)

Conditions: Idiopathic Juxtafoveal Telangiectasia
Being tested: NT-501 implant
Keywords: Mactel, Macular Telangiectasia Type 2
Medical subject headings: Idiopathic Juxtafoveal Retinal Telangiectasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NT-501 implantBiological
Ciliary neurotrophic factor (CNTF) implant

Study groups in NCT01327911
Study group	Role	What they receive
Ciliary Neurotrophic Factor (CNTF)/NT-501	Experimental	Biological/Vaccine:NT-501 implant Receives: Biological: NT-501 implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Acuity
Visual acuity decrease of >=15 letters
Measured: 3,12, 24 and 36 months

Secondary outcomes (2)

Microperimetry
Change of a 10dB at least one point either adjacent to a pre-existing scotoma or in a new area within the central 10 degrees on microperimetric testing
Measured: 12, 24 and 36 months
OCT
Change in en face area as measured by OCT
Measured: 12, 24, and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Sep 2016

First posted4 Apr 2011 (estimated)
Study startMay 2011
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Idiopathic Juxtafoveal TelangiectasiaStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01327911
Sponsor's protocol ID: NTMT-01
Status last verified: Nov 2016
First submitted: 30 Mar 2011
Last updated: 22 Nov 2016
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)
ClinicalTrials.gov ID: NCT01327911
Acronym / sponsor ID: NTMT-01
Conditions: Idiopathic Juxtafoveal Telangiectasia
Keywords: Mactel, Macular Telangiectasia Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Neurotech PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: The Lowy Medical Research Institute Limited
Study start: May 2011
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 4 Apr 2011 (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 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ciliary Neurotrophic Factor (CNTF)/NT-501	Experimental	Biological: NT-501 implantBiological/Vaccine:NT-501 implant

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

The participant must be offered sufficient opportunity to review the informed consent form, agree to the form's contents and sign the protocol's informed consent;
The participant must have bilateral MacTel;
Women of childbearing potential and all men must agree to use an effective form of birth control during the study;
Participant must be medically able to undergo ophthalmic surgery for ECT implant;
The participant's best-corrected visual acuity 64 letters or better (20/50 or better) in the study eye;

Key exclusion criteria (8 listed)

Participant is < 21 years of age;
Participant is medically unable to comply with study procedures or follow- up visits;
Participant has evidence of ocular disease other than MacTel that may confound the outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis, etc.);
Participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease, that in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted);
Participant has evidence of subretinal neovascularization in either eye;

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
NT-501 implantCiliary neurotrophic factor (CNTF) implant	Biological	Ciliary Neurotrophic Factor (CNTF)/NT-501

Primary outcome

Visual Acuity
Time frame: 3,12, 24 and 36 months
Visual acuity decrease of >=15 letters

2 secondary outcomes

Microperimetry
Time frame: 12, 24 and 36 months
OCT
Time frame: 12, 24, and 36 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 22 Nov 2016.

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.

Weng Tao study chair

Neurotech USA

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NT-501 implant in people with Idiopathic Juxtafoveal Telangiectasia, run by Neurotech Pharmaceuticals at 2 sites in United States.

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 8 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Visual Acuity (time frame: 3,12, 24 and 36 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 NCT01327911.

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 22 Nov 2016.