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Completed

NCT Number: NCT00797992

Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

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Key information

Conditions

Myopic Choroidal Neovascularization Eye Diseases Metaplasia Myopia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Refractive Errors

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Olhos de Goiania

Goiânia, Goiás, 74120-050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Injection

Drug

Intravitreal injection of 1.25 mg bevacizumab

Sponsors and collaborators

Lead sponsor

Instituto de Olhos de Goiania

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 25, 2008
Registry last updated
Nov 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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