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Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection

NCT03453281 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-07-12

No results posted yet for this study

Summary

This is a one month pre post intervention study. Subjects with diabetic macular edema were given intravitreal anti VEGF (Aflibercept) injection. Central retinal thickness, macular electrophysiology, and visual acuity were observed one week and one month after injection was given to the eye to describe early anatomical, physiological, and clinical changes. We hypothesized that changes to these outcomes can be found and documented.

Conditions

Interventions

DRUG

Aflibercept Injection [Eylea]

Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Indonesia University

    lead OTHER

Principal Investigators

  • Anggun Yudantha, dr., SpM(K) · Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

  • Syntia Nusanti, dr., SpM(K) · Dept. of Ophthalmology, Faculty of Medicine Universitas Indonesia, RSCM Kirana

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2018-04-09
Completion
2018-05-18
FDA Drug
Yes

Countries

  • Indonesia

Study Locations

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Entities

Diseases
Companies

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 NCT03453281 on ClinicalTrials.gov