Phase 2 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Recruiting NCT03161652 Sponsor: Carmen Clapp Condition: Retinal Vein Occlusion and Diabetic Macular Oedema
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Phase 2 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Recruiting

NCT03161652
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 40 and 69 years old (inclusive).
  • You are male or female and have been diagnosed with mild or moderate diabetic macular edema (a diabetes-related eye condition causing swelling), non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy and are scheduled for a medically recommended eye surgery called vitrectomy.
  • You are willing and able to sign a consent form agreeing to take part in the study.
  • You do not have serious eye complications such as severe short-sightedness (stronger than -6 diopters), clouding of the eye, or a detached retina.
  • You have not had previous eye surgeries, laser treatment on your retina, or injections into the eye within the last 6 months.
  • Your blood prolactin level (a hormone measured by a blood test) is at or below 20 ng/ml.
  • Your kidneys are working normally or with only mild reduction in function (confirm with trial site for your specific group).
  • You do not have any medical reason that would prevent you from taking a medication called levosulpiride — for example, you do not have Parkinson's disease, epilepsy, breast cancer, alcoholism, or low potassium levels.
  • You do not have any condition or take any medication known to raise prolactin levels, such as an underactive thyroid, liver problems, a prolactin-producing tumor, or certain psychiatric or stomach medications.

Who may not be able to join:

  • You do not meet the requirements listed above.
  • You experience side effects from the study medication that you cannot tolerate.
  • You are unable or unwilling to take the study medication as instructed.
  • You are unable to attend the required hospital appointments.
  • Important information about your health outcomes cannot be collected.
  • You change your mind and no longer wish to continue taking the study medication.
  • You move to a different state or country during the study.
  • You choose to withdraw your consent to participate at any time.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Carmen Clapp, Ph.D., Universidad Nacional Autonoma de Mexico (UNAM)

Phone: 52442 2381028

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Carmen Clapp
Registry
ClinicalTrials.gov
Start date
24 May 2017
Est. completion
1 December 2026

Where this trial is recruiting

🇲🇽 Mexico

Primary endpoints

Visual acuity; Retinal thickness; Retinal hard exudates and hemorrhages; Retinal microaneurisms, leakage area, cotton-wool spots, venous beading, microvascular and vascular abnormalities; Prolactin serum levels; Prolactin vitreous levels; Vasoinhibin vitreous levels

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov