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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027468
• Other study ID #: EK 548/2009
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Bevacizumab
intraocular bevacizumab injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision	Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis	3 years after first intravitreal bevacizumab treatment
Primary	CRT (Central Retinal Thickness)	Central retinal thickness measured in µm	3 years after initial intravitreal bevacizumab treatment
Secondary	Systemic Complications After Treatment		3 years after initial bevacizumab treatment