Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME

Completed · Phase 2

Conditions studied: Diabetic Macular Edema

In brief

This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME. The investigators will be evaluating patients (1-7 days) post injections for: 1\. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as measured on a standardized pain scale).

Key facts

Study ID

NCT02363621

Run by

Arshad Khanani

People needed

101

Starts

2015-01-01

Expected to finish

2017-10-01

Last updated by the study team

2019-04-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects will be eligible if the following criteria are met:
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 21 years
• Exam and OCT confirming Diabetic Macular Edema
• Visual Acuity of 20/400 or better
• No history of post injection pain or inflammation in the past

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from this study
• History of Endophthalmitis in either eye
• Current inflammation in either eye
• Uncontrolled or symptomatic Dry Eye Syndrome
• Intravitreal injection less than 3 months ago
• History of Anterior or Posterior Uveitis
• History of post injection pain with prior treatments
• Recent thromboembolic event (<3 months)
• Pregnancy (positive pregnancy test) or lactation
• Premenopausal women not using adequate contraception.

Where it is running

• Sierra Eye Associates — Reno, Nevada, United States

Full record on ClinicalTrials.gov

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