Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

Last updated: January 9, 2014
Sponsor: Instituto de Olhos de Goiania
Overall Status: Trial Status Unknown

Phase

4

Condition

Macular Degeneration

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT02033018
JJ - 3/2013
  • Ages 21-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Myopic and CNVM

Exclusion

Exclusion Criteria:

  • Patients with poor compliance

  • Patients with uncontrolled diabetes and hypertension or any other medical conditionthat increase the risk of complications like recent history of Stroke or myocardialinfraction (< one year). (Physician clearance was obtained for all patients).

  • Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVMfollowing PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentiswhich is FDA approved.

  • Patients who had undergone major surgery 28 days before, were excluded from the studyand it was also suspended prior to elective surgery.

  • Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significantmacular oedema (CSME) etc. that affects vision and does not respond adequately tousual treatment methods.

  • Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.

  • Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.

Study Design

Total Participants: 20
Study Start date:
October 01, 2013
Estimated Completion Date:
November 30, 2014

Study Description

Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months

Connect with a study center

  • Instituto de Olhos de Goiania

    Goiania, GO 74120-050
    Brazil

    Site Not Available

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