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.

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

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age Related Macular Degeneration

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

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • NJ Retina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Private practice patients referred to retinal specialist for treatment of Neovascular Age-Related Macular Degeneration

Description

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

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Subjects receiving Ranibizumab; 150 Subjects diagnosed with Neovascular Age-Related Macular Degeneration receiving Ranibizumab 0.5 mg administered by intravitreal injection.
Subjects receiving Aflibercept; 150 Subjects diagnosed with Age-related Macular Degeneration receiving Aflibercept 2 mg administered by intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept.	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.	2-3 days after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate patients 2-3 days post-injection for best corrected visual acuity	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.	2-3 days post-injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate patient's pain post-injection	Pain will be measured on a standardized pain scale; Visual Function Questionaire -25 and a 0-10 numeric pain scale.	2-3 days post-injection

Collaborators and Investigators

• Sponsor: Prism Vision Group

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Macular; Neovascular; Age related; Degeneration
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Inflammation
• Other Study ID Numbers: NJRetina ML28942; NJRetina Observational ML28942 (Other Identifier: NJRetina)