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Ranibizumab for Myopic Neovascularization

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Joao Nassaralla, Instituto de Olhos de Goiania.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Joao Nassaralla, Instituto de Olhos de Goiania Identifier:
First received: November 20, 2010
Last updated: December 31, 2013
Last verified: December 2013
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: Intervention Model: Single Group Assignment
Masking: None (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 Joao Nassaralla, 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.

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01246089

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

Responsible Party: Joao Nassaralla, MD, Instituto de Olhos de Goiania Identifier: NCT01246089     History of Changes
Other Study ID Numbers: JN-09-2010-AR
Study First Received: November 20, 2010
Last Updated: December 31, 2013

Keywords provided by Joao Nassaralla, Instituto de Olhos de Goiania:

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Refractive Errors
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on September 21, 2017