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Intravitreal Injections of Ziv-aflibercept for Macular Diseases

NCT02556723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-10-04

No results posted yet for this study

Summary

Diabetic macular edema (DME), wet-AMD and macular edema secondary to vein occlusions are the leading cause of blindness in developed countries. Several therapies have been studied as such laser treatment and intravitreal injections of corticosteroids or anti-VEGF drugs. In terms of public health the long term treatment with the current available drugs is very expensive and new therapies with the same or better effect should be investigated. This study intends to evaluate the efficacy and safety of intravitreal injections of ziv-aflibercept for the treatment of patients with DME, wet-AMD and macular edema secondary to vein occlusions.

Conditions

  • Diabetic Macular Edema
  • Age Related Macular Degeneration
  • Branch Retinal Vein Occlusion With Macular Edema
  • Central Retinal Vein Occlusion With Macular Edema

Interventions

DRUG

Intravitreal injections of ziv-aflibercept

All subjects will receive intravitreal injections of ziv-aflibercept under sterile conditions at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks. No topical or systemic antibiotics will be prescribed (pre- injection or postinjection).

Sponsors & Collaborators

  • Federal University of São Paulo

    collaborator OTHER

  • Retina Clinic, Sao Paulo, Brazil

    lead OTHER

Principal Investigators

  • André Maia, M.D. · C.E.O.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-09-30
Completion
2016-09-30

Countries

  • Brazil

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 NCT02556723 on ClinicalTrials.gov