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.

NCT01942213 | Completed

• 2 other identifiers: NJRetina ML28942NJRetina Observational ML28942
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Age Related Macular Degeneration

Keywords

Macular; Degeneration; Age related; Neovascular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate patients 2-3 days post-injection for best corrected visual acuity

  2-3 days post-injection

Other Outcomes (1)

• To evaluate patient's pain post-injection

  2-3 days post-injection

Study Arms (2)

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

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prism Vision Group: lead

Study Sites (1)

NJ Retina

Edison, New Jersey, 08820, United States

Location

Study Officials

• Daniel Roth, MD

  Prism Vision Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

US (1)