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Could a common drug save sight in diabetic patients?

NCT ID NCT03161652

Disease control Sponsor: Carmen Clapp Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether levosulpiride, a drug already used for other conditions, can safely improve vision and reduce retinal swelling in people with diabetic retinopathy and diabetic macular edema. About 120 adults aged 40-69 with mild to moderate eye damage will receive either the drug or a placebo. The goal is to see if it can control the disease and prevent further vision loss.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2017

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 69 years

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: * Age equal or greater than 40 years but no older than 69 years * Male and female subjects with mild and moderate diabetic macular edema (DME), non-proliferative diabetic retinopathy (DR), and with proliferative DR undergoing medically prescribed vitrectomy. * Signing informed consent * Without ocular complications: severe myopia (\> 6 diopters), ocular media opacity, retinal detachment, etc. * Without previous ocular treatments: ocular surgeries, retinal laser photocoagulation, intravitreal administration of antiangiogenic agents (delivered \< 6 months before enrollment). * Prolactin serum levels ≤ 20 ng/ml * With normal or mild loss of kidney function (glomerular filtration rate \>60 ml/min) for groups with DME and DR without vitrectomy. * With mild to severe loss of kidney function (glomerular filtration rate \>30 ml/min) for groups with DR undergoing vitrectomy. * Without contraindications for the use of levosulpiride (Parkinson disease, epilepsy, breast cancer, alcoholism, hypokalemia). * Without hyperprolactinemia inducing conditions: Pathologies (hypothyrodism, hepatic dysfunction, prolactinomas); Medication (antipsychotics, antidepressants, prokinetics, other) Exclusion Criteria: * Not meeting inclusion criteria. * Adverse and intolerable drug effects. * Not complying with study medication * Inability to continue in-hospital appointments. * Missing outcome data * Hesitation to continue with study medication * Relocation to another state or country * Voluntary withdrawal of consent

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Conditions

The condition(s) this trial relates to.

blindness (disorder) diabetic macular edema diabetic retinopathy Macular Edema

As listed by the trial registrant

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

Diabetic macular edema Diabetic retinopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Instituto Mexicano de Oftalmologia (IMO)

    RECRUITING

    Querétaro City, Querétaro, 76090, Mexico

  • Instituto de la Retina del Bajio SC (INDEREB)

    RECRUITING

    Querétaro City, Querétaro, 76187, Mexico

More trials for these conditions

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