A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (SIGLEC)

• ClinicalTrials.gov Identifier: NCT05839041
• Recruitment Status: Recruiting
• First Posted: May 3, 2023
• Last Update Posted: April 26, 2024
• Sponsor: Aviceda Therapeutics, Inc.
• Information provided by (Responsible Party): Aviceda Therapeutics, Inc.

Tracking Information

• First Submitted Date: April 10, 2023
• First Posted Date: May 3, 2023
• Last Update Posted Date: April 26, 2024
• Actual Study Start Date: May 2, 2023
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 20, 2023)

• Occurrence of Dose Limiting Toxicity in Part 1 [ Time Frame: 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 [ Time Frame: 12 months ]
  The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 20, 2023)

Visual Acuity Change from Baseline in Participants in Part 2 [ Time Frame: 12 months ]

The change from baseline in best-corrected visual acuity (BCVA) (assessed with ETDRS visual acuity) in Participants at Month 12

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• Brief 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Part 1 - Open Label, Multi-Center, Dose Escalation

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Part 2 - Double Masked, Randomized, Multi-Center

Primary Purpose: Treatment

Condition

• Geographic Atrophy of the Macula
• Macular Degeneration

Intervention

• Drug: AVD-104
  Intravitreal injection
• Drug: Avacincaptad
  Intravitreal injection of 2 mg avacincaptad

Study Arms

• Experimental: Part 1
  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. Participants from Part 1 will be offered the opportunity to receive monthly injections of high dose AVD-104 once the 6-month timepoint has been reached for 50% of the participants in Part 2. These participants will be followed for safety only.
  Intervention: Drug: AVD-104
• Active Comparator: Part 2: High dose AVD-104
  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.
  Intervention: Drug: AVD-104
• Active Comparator: Part 2: Low dose AVD-104
  100 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months.
  Intervention: Drug: AVD-104
• Active Comparator: Part 2: Avacincaptad
  100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)
  Intervention: Drug: Avacincaptad

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 24, 2024): 300
• Original Estimated Enrollment (submitted: April 20, 2023): 210
• Estimated Study Completion Date: June 2026
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Part 1:

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)
2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA)
3. GA may be center involved.

Part 2:

1. BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better)
2. 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.
3. 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.

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:

1. 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.
2. 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: David Callanan, MD; 617-225-4343; clinical@avicedarx.com

Contact: Keri Marchitto, MA; clinical@avicedarx.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05839041
• Other Study ID Numbers: AVD-104-C01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Aviceda Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Aviceda Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: David Callanan, MD; Aviceda Therapeutics

• PRS Account: Aviceda Therapeutics, Inc.
• Verification Date: December 2023