Bevacizumab Intravitreal for Myopic Choroidal Neovascularization - Full Text View

Sponsored by:	Instituto de Olhos de Goiania
Information provided by:	Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:	NCT00797992

Purpose

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: Injection	Phase IV

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

Further study details as provided by Instituto de Olhos de Goiania:

Enrollment:	5
Study Start Date:	January 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Myopic eyes with retinal neovascularization	Drug: Injection Intravitreal injection of 1.25 mg bevacizumab

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.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797992

Locations

Brazil, GO
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

More Information

Study ID Numbers:	JN-05-2008-AR
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797992
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Olhos de Goiania:

Bevacizumab
Myopia
Complications
Neovascularization
OCT

Study placed in the following topic categories:

Eye Diseases
Metaplasia
Choroid Diseases
Bevacizumab

Neovascularization, Pathologic
Myopia
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Antineoplastic Agents
Therapeutic Uses
Growth Substances

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009