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Investigate the Safety, Pharmacokinetics, and Treatment effects of Single and Multi-dose of Intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration.
Part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 30 participants having geographic atrophy (GA) secondary to macular degeneration. They will receive a single intravitreal injection of study drug (AVD-104) and will be followed for 3 months for safety observation. They will have both aqueous humor and peripheral blood drawn for pharmacokinetic and pharmacodynamic evaluations.
Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 on participants with geographic atrophy secondary to macular degeneration. Participants will be randomized to high dose AVD-104, low dose AVD-104, or active comparator (avacincaptad). The primary endpoint will be the difference in the rate of growth of the GA area as measured by fundus autofluorescence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Participants will receive a single intravitreal injection of AVD-104 at one of 4 escalating doses. All participants will be followed up for safety until Month 3. |
|
| Part 2: High dose AVD-104 | Active Comparator | 100 participants will be randomized and treated with bimonthly intravitreal injections of high-dose AVD-104 for the first 12 months. They will continue bimonthly injections for months 13-24. |
|
| Part 2: Low dose AVD-104 | Active Comparator | 100 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months. |
|
| Part 2: Avacincaptad | Active Comparator | 100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVD-104 | Drug | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Dose Limiting Toxicity in Part 1 | The number of participants experiencing a dose limiting toxicity corresponding to a category of 3 or greater on the National Cancer Institute Common Terminology Criteria for Adverse Events | 3 months |
| The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2 | The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of Vision Loss from Baseline in Participants in Part 2 | Proportion of participants with 15 or greater letter loss in best corrected visual acuity (BCVA) (assessed with the Early Treatment Diabetic Retinopathy Study [ETDRS] visual acuity). | 12 months |
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Inclusion Criteria:
Part 1:
Part 2:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Part 1 and 2
- Presence of the following ocular conditions - in the Study Eye:
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| Name | Affiliation | Role |
|---|---|---|
| David Callanan, MD | Aviceda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Gilbert | Arizona | 85297 | United States | ||
| Arizona Retina and Vitreous Consultants |
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Part 1 - Open Label, Multi-Center, Dose Escalation
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Part 2 - Double Masked, Randomized, Multi-Center
| Avacincaptad | Drug | Intravitreal injection of 2 mg avacincaptad |
|
| Phoenix |
| Arizona |
| 85021 |
| United States |
| Associated Retina Consultants | Scottsdale | Arizona | 85260 | United States |
| Retina Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Macula & Retina Institute | Glendale | California | 91203 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Kaiser Permanente | Riverside | California | 92505 | United States |
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95825 | United States |
| Retinal Consultants Medical Group | Sacramento | California | 95841 | United States |
| West Coast Retina | San Francisco | California | 94101 | United States |
| RCA: California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Retina Group of New England, PC | Waterford | Connecticut | 06385 | United States |
| Rand Eye Institute | Deerfield Beach | Florida | 33064 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | United States |
| Florida Retina Institute | Orlando | Florida | 32806 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | United States |
| Southern Vitreoretinal Associates | Tallahassee | Florida | 32308 | United States |
| Center for Retina & Macular Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| University Retina and Macula Associates | Chicago | Illinois | 60439 | United States |
| Illinois Retina Associates | Oak Park | Illinois | 60304 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| New England Retina Consultants | Springfield | Massachusetts | 01107 | United States |
| Retina Specialists of Michigan | Grand Rapids | Michigan | 49546 | United States |
| Associated Retinal Consultants | Royal Oak | Michigan | 48073 | United States |
| Retina Consultants of Minnesota | Minneapolis | Minnesota | 55435 | United States |
| Mississippi Retina Associates | Jackson | Mississippi | 39202 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Retina Center of New Jersey | Bloomfield | New Jersey | 07003 | United States |
| NJ Retina | Edison | New Jersey | 08820 | United States |
| Retina-Vitreous Surgeons of Central NY | Syracuse | New York | 13088 | United States |
| Long Island Vitreoretinal Consultants | Westbury | New York | 11590 | United States |
| North Carolina Retina Associates | Wake Forest | North Carolina | 27587 | United States |
| Retina Associates of Cleveland, Inc | Beachwood | Ohio | 44122 | United States |
| Retina Associates of Cleveland | Cleveland | Ohio | 44130 | United States |
| Retina Vitreous Center | Edmond | Oklahoma | 73013 | United States |
| Mid-Atlantic Retina | Bethlehem | Pennsylvania | 18017 | United States |
| Erie Retina Research, LLC | Erie | Pennsylvania | 16507 | United States |
| Retina Consultants of Charleston | Charleston | South Carolina | 29414 | United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Tennessee Retina | Nashville | Tennessee | 37203 | United States |
| Retina Research Institute of Texas Abilene TX | Abilene | Texas | 79606 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Texas Retina Associates | Fort Worth | Texas | 76104 | United States |
| Valley Retina Institute | McAllen | Texas | 78504 | United States |
| Retina Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | San Antonio | Texas | 78503 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | United States |
| Spokane Eye Clinic | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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