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New eye drug shows promise for Diabetes-Related vision loss

NCT ID NCT05301751

Disease control Sponsor: Allgenesis Biotherapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2a trial tested a new biologic drug called AG-73305, given as an injection into the eye, in 25 adults with diabetic macular edema (DME), a common cause of vision loss in people with diabetes. The study aimed to check the drug's safety and how well it works over 6 months, measuring changes in vision and retinal swelling. Because it's an early-stage study with a small number of participants, the results are preliminary but will help guide future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AG-73305 (a biologic drug given as an eye injection)
What this could lead to
If successful, this could lead to a new treatment option for diabetic macular edema that may improve vision and reduce retinal swelling.
What could go wrong
This is a small, early-phase trial with only 25 participants, so results may not apply to everyone. The drug is injected directly into the eye, which carries risks like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

May 2022

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, 18 years of age or older at the screening visit 2. Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association 3. Presence of center-involving DME in the study eye with CST ≥ 325 μm 4. Visual acuity loss in the study eye attributed to DME with screening and baseline ETDRS BCVA letter score of 20 to 55 (20/400 to 20/80 Snellen equivalent) in the sentinel patients and 35 to 70 (20/200 to 20/40 Snellen equivalent) in the non-sentinel patients 5. Cohort 1: Previously treated with an anti-VEGF in the study eye; Cohorts 2, 3, and 4: Previously treated or treatment-naïve to the study eye Exclusion Criteria: 1. Uncontrolled diabetes mellitus, defined as hemoglobin A1c \> 12.0% at Screening 2. Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline 3. Chronic renal disease 4. Any active infection in either eye 5. Any anti-vascular endothelial growth factor (VEGF) treatment in the study eye within 6 to 8 weeks prior to Baseline 6. Use of Ozurdex (dexamethasone) within 6 months prior to Baseline or any use of Iluvien (fluocinolone acetonide) in the study eye 7. Uncontrolled intraocular pressure (IOP), defined as an IOP \> 25 mmHg, despite anti-glaucoma medications in the study eye at the time of screening or controlled glaucoma that requires management with \> 2 topical hypotensive medications 8. Any anti-integrin therapy (e.g., Xiidra) within 60 days before baseline in the study eye

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Center of Macula and Retina Disease

    Winter Haven, Florida, 33880, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711, United States

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087, United States

  • Texas Retina Associates

    Fort Worth, Texas, 76104, United States

  • Valley Retina Institute

    McAllen, Texas, 78503, United States

More trials for these conditions

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