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Multimodal Image Study of Retinal Inflammation Markers After Corticoid and Antiangiogenic Treatment in Pacients With Diabetic Macular Edema

NCT03583242 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2018-07-11

No results posted yet for this study

Summary

* Main objective: Inflammation factors in imaging techniques of diabetic macular edema
* Prospective observational design
* Disease under study: Diabetic macular edema
* Methodology: Collection of the image data in the usual control (baseline visit, 4th month)
* Population under study and total number of subjects Diabetics with macular edema.
* Approximate N: 80 pacients.
* Expected duration of the study: 12 months.

Conditions

Interventions

DRUG

Antiangiogenic Agents

3 Intravitreal injections of 0.05 ml of Aflibercept (40 mg/ml) during 3 months (one per month) The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.

DRUG

Corticosteroid

1 Injection of dexamethasone intravitreal implant 0.7mg. The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.

Sponsors & Collaborators

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-23
Primary Completion
2019-06-01
Completion
2019-06-01

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03583242 on ClinicalTrials.gov