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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01942213

Enrollment

136

Registered

2013-09-13

Start date

2013-12-31

Completion date

2016-04-30

Last updated

2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age Related Macular Degeneration

Keywords

Macular, Degeneration, Age related, Neovascular

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

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

Countries

United States

Outcome results