Intravitreal Injections of Ziv-aflibercept for Macular Diseases

Sponsor
Retina Clinic, Sao Paulo, Brazil
Study ID
NCT02556723
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravitreal injections of ziv-aflibercept — DRUG
    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).

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Oct 2016
Primary completion
Sep 30, 2015
Completion
Sep 30, 2016

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ziv-aflibercept IV
    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.

Primary Outcome Measure

Multifocal electroretinogram responses at Week 24 and 48 [ Time Frame: 24 and 48 weeks ]

Related Studies