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

Primary Purpose

Geographic Atrophy of the Macula, Macular Degeneration

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AVD-104
Sham injection
Avacincaptad
Sponsored by
Aviceda Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy of the Macula focused on measuring Age-related Macular Degeneration, Geographic Atrophy, Dry AMD

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 75% of participants. Center involvement allowed in 25% 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. 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: 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.

Sites / Locations

  • Retina Vitreous Associates of FloridaRecruiting
  • Midwest Eye InstituteRecruiting
  • Cumberland Valley Retina ConsultantsRecruiting
  • Retina Research Institute of TexasRecruiting
  • Texas Retina AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Part 1

Part 2: High dose AVD-104

Part 2: Low dose AVD-104

Part 2: Sham

Part 2: Avacincaptad

Arm Description

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.

82 participants will be randomized and treated with bimonthly intravitreal injections of high-dose AVD-104 for the first 12 months. They will continue monthly injections for months 13-24.

82 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months.

82 participants will be randomized to receive sham injections monthly for 24 months

41 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Visual Acuity Change from Baseline in Participants in Part 2
The change from baseline in best-corrected visual acuity (BCVA) (assessed with ETDRS visual acuity) in Participants at Month 12

Full Information

First Posted
April 10, 2023
Last Updated
October 22, 2023
Sponsor
Aviceda Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05839041
Brief Title
A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Acronym
SIGLEC
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aviceda Therapeutics, Inc.

4. Oversight

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

5. Study Description

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, sham, or active comparator (avacincaptad) in a 2:2:2:1 ratio. The primary endpoint will be the difference in the rate of growth of the GA area between treated participants versus sham as measured by fundus autofluorescence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy of the Macula, Macular Degeneration
Keywords
Age-related Macular Degeneration, Geographic Atrophy, Dry AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Part 1 - Open Label, Multi-Center, Dose Escalation
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Part 2 - Double Masked, Randomized, Multi-Center
Allocation
Randomized
Enrollment
287 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: High dose AVD-104
Arm Type
Active Comparator
Arm Description
82 participants will be randomized and treated with bimonthly intravitreal injections of high-dose AVD-104 for the first 12 months. They will continue monthly injections for months 13-24.
Arm Title
Part 2: Low dose AVD-104
Arm Type
Active Comparator
Arm Description
82 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months.
Arm Title
Part 2: Sham
Arm Type
Sham Comparator
Arm Description
82 participants will be randomized to receive sham injections monthly for 24 months
Arm Title
Part 2: Avacincaptad
Arm Type
Active Comparator
Arm Description
41 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)
Intervention Type
Drug
Intervention Name(s)
AVD-104
Intervention Description
Intravitreal injection
Intervention Type
Procedure
Intervention Name(s)
Sham injection
Intervention Description
A sham injection with no scleral penetration
Intervention Type
Drug
Intervention Name(s)
Avacincaptad
Intervention Description
Intravitreal injection of 2 mg avacincaptad
Primary Outcome Measure Information:
Title
Occurrence of Dose Limiting Toxicity in Part 1
Description
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
Time Frame
3 months
Title
The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2
Description
The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual Acuity Change from Baseline in Participants in Part 2
Description
The change from baseline in best-corrected visual acuity (BCVA) (assessed with ETDRS visual acuity) in Participants at Month 12
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 75% of participants. Center involvement allowed in 25% 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. 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Callanan, MD
Phone
617-225-4343
Email
clinical@avicedarx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Keri Marchitto, MA
Email
clinical@avicedarx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Callanan, MD
Organizational Affiliation
Aviceda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
allison Calvanese
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Ruiz
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candace Miller
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deisy Villareal
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Flores

12. IPD Sharing Statement

Learn more about this trial

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

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