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Ranibizumab for Myopic Neovascularization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01246089
Recruitment Status : Unknown
Verified December 2013 by Joao Nassaralla, Instituto de Olhos de Goiania.
Recruitment status was:  Active, not recruiting
First Posted : November 23, 2010
Last Update Posted : January 1, 2014
Information provided by (Responsible Party):
Joao Nassaralla, Instituto de Olhos de Goiania

Brief Summary:
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 or disease Intervention/treatment Phase
Myopic Choroidal Neovascularization Drug: ranibizumab injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ranibizumabe Intravitreal Injection for Myopic Choroidal Neovascularization
Study Start Date : July 2009
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranabizumab
Myopic eyes with retinal neovascularization
Drug: ranibizumab injection
Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01246089

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

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Responsible Party: Joao Nassaralla, MD, Instituto de Olhos de Goiania Identifier: NCT01246089    
Other Study ID Numbers: JN-09-2010-AR
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: January 1, 2014
Last Verified: December 2013
Keywords provided by Joao Nassaralla, Instituto de Olhos de Goiania:
Additional relevant MeSH terms:
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Choroidal Neovascularization
Neovascularization, Pathologic
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Refractive Errors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents