Trial · NCT03161652
Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
NCT03161652, Phase 2, Recruiting, Carmen Clapp
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema. Trials, record NCT03161652. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03161652
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema
- NCT number
- NCT03161652
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Carmen Clapp
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Interventions
- DME lactose pill, DME levosulpiride, DR lactose pill, DR levosulpiride, DR vitrectomy lactose pill, DR vitrectomy levosulpiride, DME plus ranibizumab lactose pill, DME plus ranibizumab levosulpiride
- First posted
- 2017-05-22
- Last updated
- 2025-11-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual acuity | 5 minutes | Number of letters recognized in the Early Treatment Diabetic Retinopathy Study (ETDRS) chart test after correcting for any refractive error (myopia, hyperopia, or astigmatism) |
| Primary | Retinal thickness | Pupils are dilated (eye drops) for 10 to 15 minutes and optical coherence tomography (OCT) images recorded during 5 minutes. | Retinal thickness is evaluated by non-invasive optical coherence tomography (OCT) imaging via qualitative and quantitative analyses. For qualitative analyses, OCT images approaching the histological level of retinal morphology are interpreted based on normal and diseased features (hyper-reflective or hypo-reflective lesions, shadowing, and anatomical changes). Quantitative analysis evaluates retinal reflective signals and their correlation with retinal morphology by computer image-processing algorithms (retinal thickness map, volume, area, 1, 3, and 6 mm ETDRS circle diameters). |
| Primary | Retinal hard exudates and hemorrhages | Pupils are dilated (eye drops) for 10 to 15 minutes and fundus images recorded during 5 minutes | Number, size, and location of retinal hard exudates and hemorrhages evaluated by indirect ophthalmoscopy |
| Primary | Retinal microaneurisms, leakage area, cotton-wool spots, venous beading, microvascular and vascular abnormalities | 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. | Location, intensity, and source of above alterations evaluated by fundus fluorescein angiography imaging qualitative and quantitative analysis of hyper-fluorescent or hypo-fluorescent regions. |
| Primary | Prolactin serum levels | 1-2 minutes (duration of blood withdrawal) | ng/ml levels of prolactin quantified in serum samples using the IMMULITE 2000 XPi immunoassay system |
| Primary | Prolactin vitreous levels | 2 minutes (duration of vitreous withdrawal during medically prescribed vitrectomy) | ng/ml levels of prolactin quantified in vitreous samples using the IMMULITE 2000 XPi immunoassay system |
| Primary | Vasoinhibin vitreous levels | 2 minutes (duration of vitreous withdrawal during medically prescribed vitrectomy) | Optical density values of vasoinhibins obtained by the immunoprecipitation-Western blot analysis of vitreous samples |
| Secondary | Pyruvic glutamic transaminase (TGP) and thyroid stimulating hormone (TSH) serum levels | 1-2 minutes (duration of blood withdrawal) | U/L (TGP) and uU/mL (TSH) quantified in serum samples by the Bioclin Kinetic Transaminase ALT (TGP) Kit and the automatic quimioluminescent evaluator (TSH) |
| Secondary | Blood glycated hemoglobin and creatinine serum levels | 1-2 minutes (duration of blood withdrawal) | Glycated hemoglobin (evaluated by boronate affinity chromatography) and creatinine (evaluated by the Jaffe reaction) levels are expressed as % and mg/dL, respectively. |
| Secondary | Blood pressure | 5 minutes | Systolic and diastolic values in mmHg |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03161652
GET https://conductscience.org/api/trials/v1/NCT03161652/registered