← Back to Search

Other

AVD-104 for Age-Related Macular Degeneration (SIGLEC Trial)

Phase 2

Recruiting

Research Sponsored by Aviceda Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SIGLEC Trial Summary

This trial looks at the safety, effectiveness, and how a medication affects the body when used to treat age-related macular degeneration.

Who is the study for?

This trial is for people with a specific eye condition called Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD). Participants must have certain levels of vision clarity, as measured by an eye chart. They should not have the wet form of AMD or other eye conditions that might need treatment during the study.Check my eligibility

What is being tested?

The study tests multiple doses of AVD-104, given through injections into the eye, to see if it's safe and effective for treating GA in AMD patients. Some participants will receive a sham injection instead to serve as a comparison group.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, inflammation inside the eye, changes in vision, or possible allergic reactions. The full range of side effects will be monitored throughout the trial.

SIGLEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a type of age-related macular degeneration that does not affect the center of my vision.

Select...

My eye condition can be fully seen and imaged without touching the optic nerve area.

SIGLEC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Dose Limiting Toxicity in Part 1

The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2

Secondary outcome measures

Visual Acuity Change from Baseline in Participants in Part 2

SIGLEC Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Part 1Experimental Treatment1 Intervention

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.

Group II: Part 2: AvacincaptadActive Control1 Intervention

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

Group III: Part 2: High dose AVD-104Active Control1 Intervention

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.

Group IV: Part 2: Low dose AVD-104Active Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aviceda Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

21 Total Patients Enrolled

David Callanan, MDStudy DirectorAviceda Therapeutics

2 Previous Clinical Trials

245 Total Patients Enrolled

Media Library

AVD-104 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05839041 — Phase 2

Age-Related Macular Degeneration Research Study Groups: Part 2: Avacincaptad, Part 2: High dose AVD-104, Part 1, Part 2: Low dose AVD-104

Age-Related Macular Degeneration Clinical Trial 2023: AVD-104 Highlights & Side Effects. Trial Name: NCT05839041 — Phase 2

AVD-104 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05839041 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the first phase of this product been authorized by the FDA?

"There is limited evidence for the safety of Part 1, resulting in it receiving a score of 2. This Phase 2 trial does not yet have data pointing to its efficacy."

Answered by AI

To what degree is the medical trial being conducted within various healthcare centers?

"Patients are currently being recruited at Midwest Eye Institute (Indianapolis, Indiana), Cumberland Valley Retina Consultants (Hagerstown, Maryland) and the Retina Research Institute of Texas (Abilene, Texas). Additionally, a further 5 sites are participating."

Answered by AI

Are there any vacancies in this medical experiment for individuals seeking treatment?

"Clinicaltrials.gov confirms that this particular medical trial, which was initially posted on May 1st 2023 and last edited April 20th of the same year, is not presently recruiting participants. Nonetheless, there are 330 other studies actively seeking patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05839041.