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PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME

NCT03660345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-12-02

No results posted yet for this study

Summary

Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana vitrectomy with internal limiting membrane peeling will have similar visual outcomes but better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab monotherapy at one year.

Conditions

Interventions

PROCEDURE

PPV/MP

23 gauge Pars Plana Vitrectomy with Internal Limiting Membrane Peeling

DRUG

Intravitreal injection

Intravitreal ziv-Aflibercept

Sponsors & Collaborators

  • Rush Eye Associates

    lead OTHER

Principal Investigators

  • Sloan Rush · panhandle eye group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2021-05-04
Completion
2021-05-04

Countries

  • Mexico

Study Locations

More Related Trials

Entities

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 NCT03660345 on ClinicalTrials.gov