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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Geographic Atrophy of the Macula Macular Degeneration Drug: AVD-104 Drug: Avacincaptad Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
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
Actual Study Start Date : May 2, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: AVD-104
Intravitreal injection
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.
 Drug: AVD-104
Intravitreal injection
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.
 Drug: AVD-104
Intravitreal injection
Active Comparator: Part 2: Avacincaptad
100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)
 Drug: Avacincaptad
Intravitreal injection of 2 mg avacincaptad


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05839041


Contacts
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Contact: David Callanan, MD 617-225-4343 clinical@avicedarx.com
Contact: Keri Marchitto, MA clinical@avicedarx.com

Locations
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Sponsors and Collaborators
Aviceda Therapeutics, Inc.
Investigators
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Study Director: David Callanan, MD Aviceda Therapeutics
More Information
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Responsible Party: Aviceda Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05839041    
Other Study ID Numbers: AVD-104-C01
First Posted: May 3, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aviceda Therapeutics, Inc.:
Age-related Macular Degeneration
Geographic Atrophy
Dry AMD
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical