A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

Macular Telangiectasia Type 2 Clinical Trial

Official title:

A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949324
• Other study ID #: NTMT-02
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: May 22, 2017

Study information

• Verified date: September 2018
• Source: Neurotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 22, 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Macular Telangiectasia Type 2
• Telangiectasis

Intervention

Biological:
• Ciliary neurotrophic factor (CNTF)
Ciliary neurotrophic factor released from NT-501 encapsulated cell implant

Procedure:
• Sham procedure
Sham surgery for Sham arm

Device:
• NT-501 Implant
NT-501 encapsulated cell implant

Procedure:
• NT-501 Implant procedure
Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm

Locations

Country	Name	City	State
Australia	Centre for Eye Research Australia	East Melbourne
Australia	Lions Eye Institute	Nedlands
Australia	Save Sight Institute	Sydney	New South Wales
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Retina Associates of Cleveland, Inc.	Beachwood	Ohio
United States	National Eye Institute	Bethesda	Maryland
United States	Massachusetts Eye and Ear Infirmary, Retina Service	Boston	Massachusetts
United States	Jules Stein Eye Institute	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Bascom Palmer	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Neurotech Pharmaceuticals	The EMMES Corporation, The Lowy Medical Research Institute Limited

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cone density as measured by AOSLO	Change in cone density as measured by AOSLO from baseline to Months 12 and 24, in selected participants.	12 and 24 Months
Other	National Eye Institute Visual Functioning Questionnaire	Change in NEI VFQ (overall and subscale) from baseline to Months 12 and 24.	12 and 24 months
Other	Electroretinogram changes	Electroretinogram (ERG) changes from baseline to Months 6, 12 and 24, in selected clinics/participants.	6, 12 and 24 Months
Primary	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)	24 months
Secondary	Ellipsoid zone	Change in the ellipsoid zone from baseline to Month 12.	12 months
Secondary	Retinal sensitivity (dB) as measured by microperimetry	Change in retinal sensitivity (dB) as measured by microperimetry from baseline to Months 12 and 24.	12 and 24 months
Secondary	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.	12 and 24 months
Secondary	Visual Acuity	Change in best corrected visual acuity (BCVA) from baseline to Months 12 and 24.	12 and 24 months
Secondary	Visual Acuity	Proportion of study eyes with 15 or more letter loss from baseline in BCVA at Months 12 and 24.	12 and 24 Months
Secondary	Visual Acuity	Proportion of study eyes with 10 or more letter loss from baseline in BCVA at Months 12 and 24.	12 and 24 Months
Secondary	Reading Speed	Change in reading speed as measured by the IReST from baseline to Months 12 and 24.	12 and 24 Months