Ranibizumab for Myopic Neovascularization

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Joao Nassaralla, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT01246089
First received: November 20, 2010
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Myopic Choroidal Neovascularization
Drug: ranibizumab injection
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumabe Intravitreal Injection for Myopic Choroidal Neovascularization

Resource links provided by NLM:


Further study details as provided by Instituto de Olhos de Goiania:

Enrollment: 20
Study Start Date: July 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranabizumab
Myopic eyes with retinal neovascularization
Drug: ranibizumab injection
Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Myopic and CNVM

Exclusion Criteria:

  • Patients with poor compliance

    • Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients).
    • Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
    • Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
    • Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
    • Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
    • Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246089

Locations
Brazil
Instituto de Olhos de Goiania
Goiania, GO, Brazil, 74120-050
Sponsors and Collaborators
Instituto de Olhos de Goiania
  More Information

No publications provided

Responsible Party: Joao Nassaralla, MD, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier: NCT01246089     History of Changes
Other Study ID Numbers: JN-09-2010-AR
Study First Received: November 20, 2010
Last Updated: December 31, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Olhos de Goiania:
Ranibizumab
Myopia
Complications
Neovascularization
OCT

Additional relevant MeSH terms:
Myopia
Neovascularization, Pathologic
Choroidal Neovascularization
Refractive Errors
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 29, 2014