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To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration
Approximately 40 eligible subjects who have been diagnosed with intermediate Non-Exudative AMD, that require treatment will be enrolled and randomized (1.7:1) to one of 2 treatment groups:
Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected intravitreally with 1.0mg of Luminate® Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection
At the 16-week visit, the study will be unmasked to the sponsor and injecting investigator (observing investigators will remain masked). Subjects in the treatment group will receive a 2nd dose of Luminate®. Subjects in the control group will be offered the opportunity to crossover to treatment with a single dose of Luminate®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Active Comparator | Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected intravitreally with 1.0mg of Luminate® |
|
| Placebo Group | Placebo Comparator | Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risuteganib | Drug | Subjects injected intravitreally with 1.0mg of Luminate® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BCVA | 1. Percentage of population with ≥ 8 letters (1 ½ lines) BCVA gain in the Luminate group (Treatment group 1 that received 2 doses of Luminate) from baseline to study week 28 vs the Sham control group from baseline to study week 12 | 8 month total study including crossover |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Derek Kunimoto | Gilbert | Arizona | 85014 | United States | ||
| Derek Kunimoto |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35951718 | Derived | Lad EM, Boyer DS, Heier JS, Kornfield JA, Kuppermann BD, Quiroz-Mercado H, Aubel JM, Karageozian LS, Karageozian HL, Sarayba MA, Karageozian VH, Kaiser PK. Color Vision and Microperimetry Changes in Nonexudative Age-Related Macular Degeneration After Risuteganib Treatment: Exploratory Endpoints in a Multicenter Phase 2a Double-Masked, Randomized, Sham-Controlled, Crossover Clinical Trial. Ophthalmic Surg Lasers Imaging Retina. 2022 Aug;53(8):430-438. doi: 10.3928/23258160-20220725-02. Epub 2022 Aug 1. | |
| 34185587 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2019 |
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| Sham | Other | Sham injection |
|
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Retina Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Florida Eye Clinic | Altamonte Springs | Florida | 32701 | United States |
| Raj Maturi | Indianapolis | Indiana | 46290 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Derived |
| Boyer DS, Gonzalez VH, Kunimoto DY, Maturi RK, Roe RH, Singer MA, Xavier S, Kornfield JA, Kuppermann BD, Quiroz-Mercado H, Aubel J, Karageozian HL, Park JY, Karageozian VH, Karageozian L, Sarayba MA, Kaiser PK. Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A Multicenter, Phase 2a, Randomized, Clinical Trial. Ophthalmic Surg Lasers Imaging Retina. 2021 Jun;52(6):327-335. doi: 10.3928/23258160-20210528-05. Epub 2021 Jun 1. |
| Mar 6, 2019 |
| Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 16, 2021 | Sep 10, 2021 | 6 | ||
| Jul 13, 2022 | Aug 9, 2022 | 7 |
| ID | Term |
|---|---|
| C000712274 | risuteganib |
| C005703 | salicylhydroxamic acid |
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