The Effectiveness of Intravitreal Aflibercept Treatment on Exudative Age-related Macular Degeneration Patients

Obervational Study on the Effectiveness of Intravitreal Aflibercept in Exudative Age-related Macular Degeneration Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612001310853

Enrollment

184

Registered

2012-12-18

Start date

2013-01-31

Completion date

2014-11-28

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is designed as an observational study on patients being treated with 2.0mg intravitreal aflibercept for exudative age-related macular degeneration in a tertiary retinal clinic. This study does not direct therapy or recommend any treatment other than that the patients be treated in accordance with the aflibercept local product label. Efficacy of the individualized intravitreal aflibercept will be assessed by the changes in bested corrected visual acuity and macular thickness measured by optical coherence tomography, which are the routine eye examinations for monitoring this type of disease. Timing of actual patients visits is at the discretion of the treating physician. The study will be conducted for 30 months with a 6-month recruitment period and 24-month follow up period.

Interventions

The study is to evaluate the effectiveness of individualized intravitreal aflibercept in the treatment of exudative age-related macular degeneration (AMD) in routine clinical practice. Patients with previously or currently being treated with, or initiating treatment with intravitreal aflibercept for exudative AMD will be observed up to 24 months. Best corrected visual acuity and optical coherence tomography measurements will be collected at each visit if data are available.

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Previously or currently being treated with, or initiating treatment, with aflibercept for exudative AMD; and 2) Ability to provide informed consent and complete study assessments

Exclusion criteria

Pregnancy or lactation Premenopausal women not using contraception Prior anti-VEGF injection in the study eye within 28 days of baseline Prior treatment with photo dynamic therapy (PDT) within 90 days of baseline and more than 6 prior PDT treatments Significant subretinal fibrosis or atrophy Prior treatment with triamcinolone in the study eye within 6 months of baseline Intraocular surgery in the study eye within 2 months of baseline Simultaneous participation in a study that includes administration of any investigational drug or procedures.

Outcome results