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

NCT01027468 | Completed Results

• 1 other identifier: EK 548/2009
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Neovascular Age-related Macular Degeneration

Keywords

bevacizumab, choroidal neovascularization

Outcome Measures

Primary Outcomes (2)

• Vision

  Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis

  3 years after first intravitreal bevacizumab treatment

• CRT (Central Retinal Thickness)

  Central retinal thickness measured in µm

  3 years after initial intravitreal bevacizumab treatment

Secondary Outcomes (1)

• Systemic Complications After Treatment

  3 years after initial bevacizumab treatment

Study Arms (1)

group 1

EXPERIMENTAL

bevacizumab intravitreal injection

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

intraocular bevacizumab injection

Also known as: intraocular injection

group 1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Bevacizumab; Injections, Intraocular

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Assoc.Prof.PD.Dr.Stefan Sacu
• Organization: Medical University of Vienna

stefan.sacu@meduniwien.ac.at

+43404001

Study Officials

• Stefan Sacu, PD Dr.

  Department of Ophthalmology, Medical University of Vienna, Austria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 8, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 24, 2019
• Results First Posted: February 20, 2014

Record last verified: 2019-04