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Dopamine Antagonist

DME levosulpiride for Diabetic Retinopathy

Phase 2

Recruiting

Led By Ludivina Robles Osorio, M.D., Ph.D.

Research Sponsored by Carmen Clapp

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pupils are dilated (eye drops) for 10 to 15 minutes and fundus images recorded before and at different times (0.5 to 5 minutes) after fluorescein injection.

Awards & highlights

Approved for 5 Other Conditions

Summary

This is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of levosulpiride to improve retinal alterations due to diabetic macular edema and diabetic retinopathy

Eligible Conditions

Diabetic Retinopathy
Diabetic Macular Edema

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pupils are dilated (eye drops) for 10 to 15 minutes and fundus images recorded during 5 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pupils are dilated (eye drops) for 10 to 15 minutes and fundus images recorded during 5 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and pupils are dilated (eye drops) for 10 to 15 minutes and fundus images recorded during 5 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prolactin serum levels

Prolactin vitreous levels

Retinal hard exudates and hemorrhages

+4 more

Secondary study objectives

Blood glycated hemoglobin and creatinine serum levels

Blood pressure

Pyruvic glutamic transaminase (TGP) and thyroid stimulating hormone (TSH) serum levels

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: DR, vitrectomy levosulpirideExperimental Treatment1 Intervention

Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study) will be randomized to take levosulpiride.

Group II: DR levosulpirideExperimental Treatment1 Intervention

Patients with non-proliferative DR will be randomized to take levosulpiride

Group III: DME plus ranibizumab levosulpirideExperimental Treatment1 Intervention

Patients with DME that will receive intravitreal antiangiogenic therapy with ranibizumab will be randomized to take levosulpiride

Group IV: DME levosulpirideExperimental Treatment1 Intervention

Patients with DME will be randomized to take levosulpiride.

Group V: DME lactose pillPlacebo Group1 Intervention

Patients with DME will be randomized to take a lactose pill (placebo).

Group VI: DME plus ranibizumab lactose pillPlacebo Group1 Intervention

Patients with DME that will receive intravitreal antiangiogenic therapy with ranibizumab will be randomized to take a lactose pill (placebo)

Group VII: DR lactose pillPlacebo Group1 Intervention

Patients with non-proliferative DR will be randomized to take a lactose pill (placebo)

Group VIII: DR, vitrectomy lactose pillPlacebo Group1 Intervention

Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study) will be randomized to take a lactose pill (placebo).

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