This study is NOT currently recruiting participants.
Number
18-EI-0055
Sponsoring Institute
National Eye Institute (NEI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 21 Years Max Age: 80 Years
Referral Letter Required
No
Population Exclusion(s)
Adults who are or may become unable to consent;Pregnant Women;Children
Keywords
MacTel; Ciliary Neurotrophic Factor
Recruitment Keyword(s)
None
Condition(s)
Macular Telangiectasia
Investigational Drug(s)
NT-501
Investigational Device(s)
Intervention(s)
Procedure/Surgery: NT-501 Procedure/Surgery: Sham
Supporting Site
National Eye Institute
People with the eye disease Macular Telangiectasia Type 2 (MacTel) often lose vision. The molecule ciliary neurotrophic factor (CNTF) might keep some eye cells healthy. Previously, releasing CNTF from a small capsule in the eye helped people with MacTel. Researchers want to test the capsule again and compare results.
Objectives:
To test if releasing CNTF from a small capsule implanted in the eye helps people with MacTel.
Eligibility:
Adults 21-80 years old with MacTel
Design:
Participants will be screened with:
-Medical history
-Physical exam
-Vital signs
-Eyes dilated, measured, photographed
-Eye tests with flashing lights, laser scan, dye injected in an arm
-Reading tests
-Vision questions
-Urine pregnancy tests
-Blood tests
Participants will be randomly assigned to Group A or B. Participants and testing staff will not know which group participants are in.
All participants will have surgery:
-Eyedrops will dilate and numb the eye
-Participants may have a numbing injection and medicine to make them sleepy.
-Group A: The capsule will be implanted and held with a permanent stitch on the white of the eye. The outside of the eye will be closed with stitches that get absorbed. An injection will reduce swelling.
-Group B: Doctors will make a small cut in the eye and place only the absorbable stitches. They will talk like they are doing the implant surgery. They may give a pretend injection.
-All participants will get eyedrops for infection and swelling and need a ride home. They will wear an eyepatch for several hours.
Participants will have 7 visits and 2 calls over 2 years.
Visits may include:
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INCLUSION CRITERIA: To participate in this study, the potential participant and at least 1 of their eyes must meet all of the following criteria: 1. Participant must have at least 1 study eye with a positive diagnosis of MacTel with evidence of fluorescein leakage typical of MacTel and at least one of the other features that include hyperpigmentation that is outside of a 500 micron radius from the center of the fovea, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities 2. Participant must have an IS/OS PR break and EZ (area of IS/OS loss) as measured by SD-OCT between 0.16 and 2.00 mm^2 3. Participant s BCVA is 54-letter score or better (20/80 or better) as measured by the ETDRS chart at screening 4. Participant must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality photographs 5. Participant must be greater than 21 years of age or less than 80 years of age at screening 6. Participant must be able to provide written informed consent to participate in the study, in accordance with the ICH GCP guidelines, and local regulations, before initiating any study-related procedures EXCLUSION CRITERIA: To participate in this study, the potential participant must not meet any of the following criteria. The ocular exclusion criteria are related to the study eye (unless indicated for either eye): 1. Participant is medically unable to comply with study procedures or follow-up visits 2. Participant received intravitreal steroid therapy for nonneovascular MacTel within the last 3 months 3. 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 therapy in the fellow eye at randomization 4. 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 (eg, glaucoma, severe nonproliferative or proliferative diabetic retinopathy, uveitis) 5. Participant has a chronic requirement (eg, greater than or equal to 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) 6. Participant has evidence of intraretinal neovascularization or SRNV, as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye 7. Participant has evidence of central serous chorioretinopathy in either eye 8. Participant has evidence of pathologic myopia in either eye 9. Participant has significant corneal or media opacities in either eye 10. Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty 11. Participant has any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or a nuclear opacity > standard 3 as measured on the Age-Related Eye Disease Study (AREDS) clinical lens grading system 12. Participant has undergone lens removal in the previous 3 months or YAG laser within 4 weeks 13. Participant was a participant in any other clinical trial of an intervention (drug or device) within the last 6 months 14. Participant is on chemotherapy 15. Participant is pregnant or breastfeeding 16. Participant has a history of malignancy that would compromise the 24-month study survival 17. Participant with a history of ocular herpes virus in either eye 18. Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments 19. Participant has evidence of intraretinal hyperreflectivity by OCT
To participate in this study, the potential participant and at least 1 of their eyes must meet all of the following criteria:
1. Participant must have at least 1 study eye with a positive diagnosis of MacTel with evidence of fluorescein leakage typical of MacTel and at least one of the other features that include hyperpigmentation that is outside of a 500 micron radius from the center of the fovea, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities
2. Participant must have an IS/OS PR break and EZ (area of IS/OS loss) as measured by SD-OCT between 0.16 and 2.00 mm^2
3. Participant s BCVA is 54-letter score or better (20/80 or better) as measured by the ETDRS chart at screening
4. Participant must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality photographs
5. Participant must be greater than 21 years of age or less than 80 years of age at screening
6. Participant must be able to provide written informed consent to participate in the study, in accordance with the ICH GCP guidelines, and local regulations, before initiating any study-related procedures
EXCLUSION CRITERIA:
To participate in this study, the potential participant must not meet any of the following criteria. The ocular exclusion criteria are related to the study eye (unless indicated for either eye):
1. Participant is medically unable to comply with study procedures or follow-up visits
2. Participant received intravitreal steroid therapy for nonneovascular MacTel within the last 3 months
3. 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 therapy in the fellow eye at randomization
4. 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 (eg, glaucoma, severe nonproliferative or proliferative diabetic retinopathy, uveitis)
5. Participant has a chronic requirement (eg, greater than or equal to 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)
6. Participant has evidence of intraretinal neovascularization or SRNV, as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye
7. Participant has evidence of central serous chorioretinopathy in either eye
8. Participant has evidence of pathologic myopia in either eye
9. Participant has significant corneal or media opacities in either eye
10. Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty
11. Participant has any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or a nuclear opacity > standard 3 as measured on the Age-Related Eye Disease Study (AREDS) clinical lens grading system
12. Participant has undergone lens removal in the previous 3 months or YAG laser within 4 weeks
13. Participant was a participant in any other clinical trial of an intervention (drug or device) within the last 6 months
14. Participant is on chemotherapy
15. Participant is pregnant or breastfeeding
16. Participant has a history of malignancy that would compromise the 24-month study survival
17. Participant with a history of ocular herpes virus in either eye
18. Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments
19. Participant has evidence of intraretinal hyperreflectivity by OCT
Principal Investigator
Referral Contact
For more information: