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Could a daily pill help save sight in diabetic retinopathy?

NCT ID NCT04692688

Disease control Sponsor: Ocuphire Pharma, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an oral medication called APX3330 in 103 adults with moderate to severe diabetic retinopathy, a leading cause of vision loss. The pill aims to reduce inflammation and low-oxygen stress in the eye. Researchers measured whether the drug could improve the severity of the disease over 24 weeks compared to a placebo.

What this could mean

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

Active substance
APX3330 (an oral tablet that targets inflammation and low-oxygen signals in the eye)
What this could lead to
If it works, this could provide a convenient pill-based option to slow or improve diabetic retinopathy, reducing the need for eye injections or laser treatment.
What could go wrong
This is a small Phase 2 trial with only 103 participants, so results may not be conclusive. The drug may not show enough benefit or could have side effects not yet seen.

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

103 people

The number who actually took part.

Started

Apr 2021

Finished

Jan 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

Accepted

You do not need to have the condition being studied to take part.

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. Males or non-pregnant females ≥ 18 years of age 2. At least one eye with DR graded at least moderately severe to severe NPDR or mild PDR (corresponding to DRSS 47, 53, or 61) 3. BCVA assessed by ETDRS protocol letters score of ≥ 60 letters (Snellen equivalent ≥ 20/63) 4. Body mass index (BMI) between 18 and 40 kg/m2, inclusive Exclusion Criteria: Ophthalmic: 1. Any prior treatment in the study eye with: 1. Focal or grid laser photocoagulation within the past year or PRP at any time 2. Systemic or intravitreal anti-VEGF agents within the last 6 months 3. Intraocular steroids including triamcinolone and dexamethasone implant within the last 6 months 4. Fluocinolone implant within the last 3 years 2. Active uveitis, vitritis, or infection in either eye including infectious conjunctivitis, keratitis, scleritis, or endophthalmitis. 3. Ocular incisional surgery including cataract surgery in the study eye within 3 months. 4. Clinically significant ocular disease in either eye. 5. Presence of macular or retinal vascular disease including diabetic macular edema, retinopathy from causes other than diabetes, age-related macular degeneration, pattern dystrophy, choroidal neovascularization of any cause, retinal vein occlusion, retinal artery occlusion in the study eye. 6. History of retinal detachment, full-thickness macular hole in the study eye, or idiopathic or autoimmune uveitis in either eye. Systemic: 1. Known hypersensitivity or contraindication to study drug. 2. Any disease or medical condition that in the opinion of the Investigator would interfere with the study, prevent the subject from successfully participating in the study, or which might confound the study results. 3. Participation in any investigational study within 30 days prior to screening or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion. 4. Resting HR outside the specified range (50-110 beats per minute). 5. Known to be immunocompromised or receiving immunosuppressive therapy. 6. Hypertension with resting diastolic blood pressure (BP) \> 105 mmHg or systolic BP \> 200 mmHg. 7. History of chronic liver disease or presence of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) consistent with such diagnosis. 8. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

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Conditions

The condition(s) this trial relates to.

background diabetic retinopathy diabetes mellitus diabetic macular edema diabetic retinopathy proliferative diabetic retinopathy

As listed by the trial registrant

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

Diabetic macular edema Diabetic retinopathy NPDR - non proliferative diabetic retinopathy PDR - proliferative diabetic retinopathy

Contacts and locations

Locations

  • Clinical Site 1

    Rapid City, South Dakota, 57701, United States

  • Clinical Site 10

    Fort Worth, Texas, 76104, United States

  • Clinical Site 11

    Palm Desert, California, 92260, United States

  • Clinical Site 12

    Albuquerque, New Mexico, 87113, United States

  • Clinical Site 13

    Southlake, Texas, 76092, United States

  • Clinical Site 14

    Hagerstown, Maryland, 21740, United States

  • Clinical Site 15

    Shirley, New York, 11967, United States

  • Clinical Site 16

    Bellaire, Texas, 77030, United States

  • Clinical Site 17

    Grand Blanc, Michigan, 48439, United States

  • Clinical Site 18

    Austin, Texas, 78705, United States

  • Clinical Site 19

    Miami, Florida, 33143, United States

  • Clinical Site 2

    Sacramento, California, 95825, United States

  • Clinical Site 20

    Charlotte, North Carolina, 28210, United States

  • Clinical Site 21

    Ogden, Utah, 84010, United States

  • Clinical Site 22

    Springfield, Massachusetts, 01107, United States

  • Clinical Site 23

    San Antonio, Texas, 78624, United States

  • Clinical Site 24

    Walnut Creek, California, 94598, United States

  • Clinical Site 3

    San Antonio, Texas, 78240, United States

  • Clinical Site 4

    McAllen, Texas, 78550, United States

  • Clinical Site 5

    Beverly Hills, California, 91607, United States

  • Clinical Site 6

    Carmel, Indiana, 46290, United States

  • Clinical Site 7

    Winter Haven, Florida, 33880, United States

  • Clinical Site 8

    Bakersfield, California, 93309, United States

  • Clinical Site 9

    Phoenix, Arizona, 85014, United States

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