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AG-73305 for Diabetic Macular Edema

Phase 2
Recruiting
Research Sponsored by Allgenesis Biotherapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of center-involving DME in the study eye with CST ≥ 325 μm
Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to 6 months
Awards & highlights

Study Summary

This trial is testing a new drug for people with diabetes who have a condition called diabetic macular edema. The drug is given as a shot into the eye, and different doses are being tested to see how well it works.

Who is the study for?
This trial is for adults over 18 with diabetic macular edema (DME) affecting the center of the retina and vision loss due to DME. Participants must have a certain level of central retinal thickness and visual acuity. Excluded are those with recent treatments like Ozurdex or Iluvien, uncontrolled diabetes or high blood pressure, chronic kidney disease, eye infections, high eye pressure, or recent anti-VEGF treatment.Check my eligibility
What is being tested?
The study tests different doses of AG-73305 given as an injection inside the eye to people with DME. It's an open-label trial where everyone knows what treatment they're getting. The goal is to find out how safe it is and how well it works at various dose levels.See study design
What are the potential side effects?
While specific side effects for AG-73305 aren't listed here, similar treatments may cause eye irritation or redness, increased intraocular pressure, bleeding in the eyes, cataract formation, and potential risk of infection from injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My eye condition involves swelling in the center with a thickness of 325 μm or more.
Select...
I have been diagnosed with diabetes (Type 1 or Type 2).
Select...
My vision loss due to DME falls within the specified range for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to 6 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
Safety as Assessed by Incidence of Adverse Events (AEs) and Serious AEs (SAE)
Secondary outcome measures
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Mean change from baseline in central subfield thickness (CST)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
A single IVT dose of 3 mg AG-73305
Group II: Cohort 3Experimental Treatment1 Intervention
A single IVT dose of 2 mg AG-73305
Group III: Cohort 2Experimental Treatment1 Intervention
A single IVT dose of 1 mg AG-73305
Group IV: Cohort 1Experimental Treatment1 Intervention
A single intravitreal (IVT) dose of 0.5 mg AG-73305

Find a Location

Who is running the clinical trial?

Allgenesis Biotherapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
148 Total Patients Enrolled
Lexitas Pharma Services, Inc.Industry Sponsor

Media Library

AG-73305 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05301751 — Phase 2
Diabetic Macular Edema Research Study Groups: Cohort 1, Cohort 2, Cohort 3, Cohort 4
Diabetic Macular Edema Clinical Trial 2023: AG-73305 Highlights & Side Effects. Trial Name: NCT05301751 — Phase 2
AG-73305 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301751 — Phase 2

Frequently Asked Questions

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

How many individuals are actively participating in the experiment?

"Affirmative, the clinical trials website confirms that this medical experiment is still open to applicants. It was initially published on June 9th 2022 and has been recently revised as of June 29th 2022. 25 individuals need to be enrolled from 2 centres."

Answered by AI

What potential risks have been identified with AG-73305?

"Due to the lack of efficacy data and presence of safety information, our team has assigned AG-73305 a score of 2 on the 1-3 scale."

Answered by AI

Is this experiment presently open for enrollment?

"Affirmative. According to clinicaltrials.gov, this medical research is actively seeking volunteers after being posted on June 9th 2022 and last edited on June 29th of the same year. The trial requires 25 participants from 2 sites."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~9 spots leftby Mar 2025