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This is a two armed Single Masked Pilot Study enrolling participants with Macular Telangiectasia Type 2 who will be randomized to undergo either a subthreshold photothermal treatment or a sham procedure to one eye. The participants will be followed for one year with visits at 1 month, 3 months, 6 months and 12 months post-treatment (laser or sham). Due to the small number of participants enrolled in this study the data will be analyzed by descriptive statistics and exploratory figures. Summary statistics will be produced for study and fellow eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subthreshold Photothermal Therapy | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 577-nm PASCAL laser | Device | The Topcon/Endpoint Management Systemâ„¢ is a cleared medical device commonly used in the treatment of ocular disorders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | To evaluate the safety and tolerability of subthreshold photothermal therapy in patients with MacTel Type 2 as assessed by CTCAE v4.0 | 3 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline cone density as measured by confocal adaptive optics (AOSLO) | To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2. | 1 year |
| Change in size of ellipsoid zone break area as measured by spectral domain optical coherence tomography (SD-OCT) |
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Inclusion Criteria:
Signed and dated written informed consent obtained from the participant in accordance with the local regulations;
Males/females 21 years of age and older but less than 80 years of age;
Participant must have a positive diagnosis of MacTel Type 2 in at least one eye with evidence of fluorescein leakage typical of MacTel or at least one of the other features including loss of retinal transparency/hyper-reflectivity to blue light, crystalline deposits, right angle vessels, inner/outer retinal low-reflective spaces, or hyperpigmentation not involving the center of the fovea, but no evidence of intraretinal/subretinal vascular proliferation;
Participant must have an Ellipsoid Zone (EZ, aka IS/OS) break in the study eye between 0.16 - 4.0 mm2 as measured on SD-OCT;
Participant's best-corrected visual acuity at least 55 letters (20/80) in the study eye;
Participant must have steady fixation in the foveal or parafoveal area of each eye, adequate pupil dilation and sufficiently clear media to perform multi-modal retinal imaging and treatment;
Participant must be able and willing to attend all scheduled visits.
For Participants undergoing optional AOSLO imaging:
Participant should have reproducible baseline AOSLO image montages at 2 baseline imaging sessions with quality suitable to identify a minimum of 7 regions of interest (ROIs) at which reliable cone spacing measures can be made in each eye.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin & Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
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To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2. |
| 1 year |
| Development or extension post therapy of areas of deficiency in cones as measured by AOSLO | To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2. | 1 year |