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New Dual-Action eye drug shows promise in early trial for Diabetes-Related vision loss

NCT ID NCT05940428

Disease control Sponsor: Visara, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tested a new eye injection called ASKG712 in 10 people with diabetic macular edema, a condition where fluid builds up in the retina and blurs vision. The drug targets two proteins that cause leakage and abnormal blood vessel growth. The main goal was to check safety and how the body processes the drug, not yet to prove it works. Results will guide future larger studies.

What this could mean

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

Active substance
ASKG712 (a protein injection that blocks two factors involved in abnormal blood vessel growth and leakage)
What this could lead to
If successful, this could lead to a new treatment option for diabetic macular edema that targets two pathways at once, potentially offering better or longer-lasting vision improvement.
What could go wrong
This is a very early (Phase 1) study with only 10 participants, so safety and dosing are the main focus—not yet proof of effectiveness. The treatment 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2024

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. Documented diagnosis of diabetes mellitus (Type 1 or Type 2) 2. Hemoglobin A1c of less than or equal to 12% 3. For women of childbearing potential: agreement to use acceptable contraceptive methods during the treatment period and for at least 90 days after the final dose of study treatment 4. Ability and willingness to undertake all scheduled visits and assessments 5. Macular thickening secondary to DME involving the center of the fovea 6. Decreased visual acuity attributable primarily to DME Exclusion Criteria: 1. History of allergy or current allergic response to ASKG712 or fluorescein 2. Diseases that affect intravenous injection and venous blood sampling 3. Uncontrolled blood pressure 4. Systemic autoimmune diseases 5. Previous anti-VEGF drug treatment 6. Currently pregnant or breastfeeding, or intend to become pregnant during the study 7. Any uncontrolled clinical disorders 8. Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye 9. History of intraocular or periocular corticosteroid treatment in the study eye 10. Uncontrolled previous or current glaucoma in the study eye 11. Previous intraocular operations in the study eye 12. Active intraocular or periocular infection or active intraocular inflammation in the study eye 13. History of uveitis in either eye 14. Other protocol-specified inclusion/exclusion criteria may apply

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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

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.