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.

Neovascular 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: Completed

Administrative data

• NCT number: NCT01942213
• Other study ID #: NJRetina ML28942
• Secondary ID: NJRetina Observa
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: May 31, 2016
• Start date: December 2013
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: NJ Retina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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.

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

Other known NCT identifiers

• NCT01991730

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: April 2016
• Est. primary completion date: April 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

• Macular Degeneration
• Neovascular Age Related Macular Degeneration
• Wet Macular Degeneration

Locations

Country	Name	City	State
United States	NJ Retina	Edison	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; Visual Function Questionaire -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.	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 Early Treatment Diabetic Retinopathy Study eye chart at a starting test distance of 4 meters.	2-3 days post-injection	No