Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration
This study has been completed.
Information provided by (Responsible Party):
Joao Nassaralla, Instituto de Olhos de Goiania
First received: November 9, 2007
Last updated: November 19, 2011
Last verified: November 2011
To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal neovascularization secondary to age-related macular degeneration.
Age Related Macular Degeneration
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration
Primary Outcome Measures:
- Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Ocular side effects (infection, RD, IOP rise, cataract)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2007 (Final data collection date for primary outcome measure)
We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
- 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.
- 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).
- Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556348
Instituto de Olhos de Goiania
||Joao J Nassaralla, Jr
||UnB and IOG
No publications provided
||Joao Nassaralla, MD, Instituto de Olhos de Goiania
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 9, 2007
||November 19, 2011
||Brazil: National Health Surveillance Agency
Keywords provided by Instituto de Olhos de Goiania:
Age Macular Degeneration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 12, 2014
Angiogenesis Modulating Agents
Physiological Effects of Drugs