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: Neovascular Age Related Macular Degeneration

• Registration Number: NCT01942213
• Lead Sponsor: Prism Vision Group

Brief 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.

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Study Start: 2013-12
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• 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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept.	2-3 days after injection	All eyes will be evaluated 2-3 days after injection and graded in terms of (a) aqueous cells, graded subjectively on a scale of 0-4, (b) aqueous flare, graded subjectively on a scale 0-4, (c) aqueous flare graded objectively with the FM-600 Kowa flare meter and (d) vitreous haze, graded subjectively on a scale of 0-4.

Secondary Outcome Measures

Name	Time	Method
To evaluate patients 2-3 days post-injection for best corrected visual acuity	2-3 days post-injection	Best corrected visual acuity will be assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study eye chart at a starting test distance of 4 meters.

Trial Locations

Locations (1)

NJ Retina; 🇺🇸 Edison, New Jersey, United States