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Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

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ClinicalTrials.gov Identifier: NCT00797992
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : November 25, 2008
Sponsor:
Information provided by:
Instituto de Olhos de Goiania

Brief Summary:
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: Injection Phase 4

Detailed Description:
Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab Intravitreal for Myopic Choroidal Neovascularization
Study Start Date : January 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Myopic eyes with retinal neovascularization
Drug: Injection
Intravitreal injection of 1.25 mg bevacizumab




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

Inclusion Criteria:

  • Myopic 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 ClinicalTrials.gov identifier (NCT number): NCT00797992


Locations
Brazil
Instituto de Olhos de Goiania
Goiania, GO, Brazil, 74120-050
Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
Study Chair: Joao J Nassaralla, PhD Instituto de Olhos de Goiania

ClinicalTrials.gov Identifier: NCT00797992     History of Changes
Other Study ID Numbers: JN-05-2008-AR
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: November 25, 2008
Last Verified: November 2008

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

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Myopia
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Refractive Errors
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents