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

Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01991730
• Other study ID #: NJRetina-ML28942
• Secondary ID: NJRetina Observa
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2013
• Last updated: April 20, 2015
• Start date: October 2013

Study information

• Verified date: April 2015
• Source: NJ Retina
• Contact: Daniel Roth, MD
• Phone: 732-220-1600
• Email: rothretina[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

THIS IS AN OBSERVATION STUDY AND NOT AN INTERVENTIONAL STUDY AS TO ENTER THIS STUDY SUBJECTS WILL HAVE HAD TO RECEIVED EITHER RANIBIZUMAB 0.5 MG OR AFIBERCEPT 2MG PRIOR TO ENTERING THE STUDY AND SIGNING CONSENT. THIS STUDY IS TO OBSERVE THE SUBJECT POST-INJECTION RECEIVED BEFORE ENTERING THIS STUDY.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
United States	NJ Retina	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
NJ Retina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate patient's pain post-injection	Pain will be measured on a standardized pain scale; VFQ-25 and a 0-10 numeric pain scale.	2-3 days post-injection	No
Primary	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.	Study eyes will be evaluated 2-3 days after injection	Yes
Secondary	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 ETDRS eye chart at a starting test distance of 4 meters.	2-3 days post-injection	No