A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
NCT05839041
Phase
Phase 2
Recruitment status
Completed
Participants
Lead sponsor
Aviceda Therapeutics, Inc.
Start date
2023-05-02
Number of sites
- Summary
- 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.
- Acronym
- SIGLEC
- Short title
- A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
- Official title
- A Single and Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Treatment Effect of Intravitreal AVD-104 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-02-18
- First posted
- 2023-05-03
- Registry last updated
- 2026-09-16
- Primary completion date
- 2026-02-18
- Start date
- 2023-05-02
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Aviceda Therapeutics, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05839041
- ClinicalTrials.gov ID
- NCT05839041
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masking description
- Part 2 - Double Masked, Randomized, Multi-Center
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Occurrence of Dose Limiting Toxicity in Part 1
Timeframe: 3 months
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
The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2
Timeframe: 12 months
The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12.
Prevention of Vision Loss from Baseline in Participants in Part 2
Timeframe: 12 months
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).
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 55 Years
- Maximum age
- 90 Years
- Healthy volunteers
- No
Part 1:
- BCVA in the study eye using ETDRS Chart Visual Acuity Scale (VAS) of 5 to 55 letters (equivalent to Snellen VA of approximately 20/800 - 20/80)
- If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA)
- GA may be center involved.
Part 2:
- BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better)
- Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA in 50% of participants. Center involvement allowed in 50% of participants.
- The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
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:
- Exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography (SD-OCT) imaging and/or fluorescein angiography as assessed by the Reading Center.
- Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
Sources for eligibility
- Associated Retina ConsultantsGilbert, United States
- Arizona Retina and Vitreous ConsultantsPhoenix, United States
- Associated Retina ConsultantsScottsdale, United States
- Retina Vitreous Associates Medical GroupBeverly Hills, United States
- Macula & Retina InstituteGlendale, United States
- Northern California Retina Vitreous AssociatesMountain View, United States
- Kaiser PermanenteRiverside, United States
- Retinal Consultants Medical Group, Inc.Sacramento, United States
- Retinal Consultants Medical GroupSacramento, United States
- West Coast RetinaSan Francisco, United States
- RCA: California Retina ConsultantsSanta Barbara, United States
- Retina Group of New England, PCWaterford, United States
- Rand Eye InstituteDeerfield Beach, United States
- Retina Group of FloridaFort Lauderdale, United States
- Florida Retina InstituteOrlando, United States
- Retina Specialty InstitutePensacola, United States
- Retina Vitreous Associates of FloridaSt. Petersburg, United States
- Southern Vitreoretinal AssociatesTallahassee, United States
- Center for Retina & Macular DiseaseWinter Haven, United States
- Southeast Retina CenterAugusta, United States
- University Retina and Macula AssociatesChicago, United States
- Illinois Retina AssociatesOak Park, United States
- Midwest Eye InstituteIndianapolis, United States
- Cumberland Valley Retina ConsultantsHagerstown, United States
- Ophthalmic Consultants of BostonBoston, United States
And 31 more, listed on the interactive page.
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Macular degeneration Primary condition