Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration

NCT ID: NCT01027468

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2009-12-31

Brief Summary

200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).

Detailed Description

In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1

bevacizumab intravitreal injection

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

intraocular bevacizumab injection

Interventions

Bevacizumab

intraocular bevacizumab injection

Intervention Type: DRUG

Other Intervention Names

intraocular injection

Eligibility Criteria

Inclusion Criteria

• any subtype of neovascular age-related macular degeneration
• age of 50 years or older
• initial treatment with intravitreal bevacizumab between August 2005 and June 2006

Exclusion Criteria

• previous vitrectomy
• presence of cystoid macular edema without choroidal neovascularization
• Uncontrolled systemic disease

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Stefan Sacu

Assoc. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Sacu, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Medical University of Vienna, Austria

Other Identifiers

EK 548/2009

Identifier Type: -

Identifier Source: org_study_id