Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients.

Completed

Conditions studied: Neovascular Age Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT01942213

Run by

Prism Vision Group

People needed

136

Starts

2013-12-01

Expected to finish

2016-04-01

Last updated by the study team

2016-06-01

Who can join

Age: 65 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age 65-90 years
• Diagnosis or Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept

You may not qualify if…

• 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

Where it is running

• NJ Retina — Edison, New Jersey, United States

Full record on ClinicalTrials.gov

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