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Dopamine Antagonist
Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
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
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 moreSecondary 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).
Find a Location
Who is running the clinical trial?
Instituto de Neurobiología, Universidad Nacional Autonoma de Mexico (UNAM)UNKNOWN
Universidad Autónoma de QuerétaroOTHER
Instituto Mexicano de Oftalmologia (IMO)UNKNOWN
Instituto de la Retina del Bajio SC (INDEREB)UNKNOWN
Carmen ClappLead Sponsor
General Hospital Nuremberg & Paracelsus Medical University NurembergUNKNOWN
Carmen Clapp, Ph.D.Study DirectorUniversidad Nacional Autonoma de Mexico (UNAM)
Ludivina Robles Osorio, M.D., Ph.D.Principal InvestigatorUniversidad Autónoma de Querétaro
Renata Garcia Franco, M.D.Principal InvestigatorInstituto de la Retina del Bajio SC (INDEREB)
Jakob Triebel, M.D.Principal InvestigatorInstitute for Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Nuremberg General Hospital