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Clinical Trial Summary

This open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection.

Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.


Clinical Trial Description

Patients, age 65 to 90, with Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300 subjects from one site in the United States will be enrolled.

Inclusion Criteria:

- Ability to provide written informed consent and comply with study

- Age 65-90 years

- Diagnosis of Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept

Exclusion Criteria:

- Previous intraocular inflammation

- Treatment with systemic anti-inflammatory agents

- Known systemic autoimmune diseases

- Treatment with intraocular steroids in the past 3 months

- History of intraocular surgery in the past 3 months

- Age greater than 90 years

- Patients who were switched between either therapies in the past 3 months ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01942213
Study type Observational
Source NJ Retina
Contact
Status Completed
Phase N/A
Start date December 2013
Completion date April 2016

See also
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