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| Name | Class |
|---|---|
| i-Lumen Scientific, Inc. | INDUSTRY |
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The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active i-Lumen AMD therapy | Experimental | Active transpalpebral microcurrent therapy |
|
| Sham i-Lumen AMD therapy | Sham Comparator | Sham transpalpebral microcurrent therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-Lumen AMD | Device | i-Lumen AMD transpalpebral microcurrent stimulation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change BCVA from Baseline | Mean change in per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Portion of per-eye Responders | 1. Difference in proportion of per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) gaining ≥10 letters from Baseline in distance BCVA ETDRS, active vs sham. | Month 3 |
| Mean Change BCVA from Baseline |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meredith Mundy | Contact | 408-440-7049 | mmundy@i-lumen.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Meredith Mundy | i-Lumen Scientific AUS PTY LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants PC | Not yet recruiting | Manchester | Connecticut | 06042 | United States |
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2:1 Randomization of active to sham therapy
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Mean change in per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham. |
| Month 6 |
| University Retina & Macula Associates | Not yet recruiting | Lemont | Illinois | 60439 | United States |
|
| Texas Retina Associates | Not yet recruiting | Fort Worth | Texas | 76104 | United States |
|
| Tyler Retina Research Insitute | Not yet recruiting | Tyler | Texas | 75703 | United States |
|
| Sydney Eye Hospital | Recruiting | Sydney | New South Wales | 2000 | Australia |
|
| Hobart Eye Surgeons | Recruiting | Hobart | Tasmania | 7000 | Australia |
|
| Adelaide Eye & Retina Centre | Recruiting | Adelaide | Victoria | 5000 | Australia |
|
| Cerulea | Recruiting | East Melbourne | Victoria | Australia |
|
| Auckland Eye Limited | Recruiting | Remuera | Auckland | 1050 | New Zealand |
|
| Southern Eye Specialist | Recruiting | Christchurch | New Zealand |
|
| King's College Hospital | Recruiting | London | SE5 9RS | United Kingdom |
|
| London North West University Healthcare | Recruiting | Middlesex | HA1 3UJ | United Kingdom |
|
| Sunderland Eye Infirmary | Recruiting | Sunderland | SR2 9HP | United Kingdom |
|
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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