Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration

Evaluation of Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections

This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-Related Macular Degeneration
• Intervention / Treatment: Drug: Ranibizumab 0.5mg; Drug: Aflibercept 2.0mg

Detailed Description

This is an open-label, Phase I-II study of post injection pain and inflammation after intravitreally administered Ranibizumab and Aflibercept in 100 subjects with Neovascular Age-Related Macular Degeneration. We will enroll both treatment experienced ( patients who were treated with Lucentis or Eylea, but not Avastin in the past) and treatment naive patients ( new onset Neovascular AMD with no history of intravitreal injections).

The treatment experienced patients will be treated with the intravitreal medication other than what they were receiving in the past, for example, patients treated with Lucentis will switch to Eylea for study purposes and vice versa.

Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg Ranibizumab or 2mg Aflibercept. A standard intravitreal injection protocol will be followed. Patients will be reevaluated between 24-48 hours and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenclature (SUN) working group classifications.

Pain score will be evaluated using a Numerical Rating Scale. Each patient will have a standard script verbally read to them at their visit, and asked to rate their pain based on this scale.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to provide informed consent and comply with study assessments for the full duration of the study
2. Age >/= 65 years
3. New onset Neovascular Age-Related Macular Degeneration or (See No.4)
4. Previously treated Neovascular Age-Related Macular Degeneration with Lucentis or Eylea intravitreal injections
5. Visual Acuity of 20/400 or better
6. No history of Post injection pain or inflammation with prior treatments -

Exclusion Criteria:

1. History of Endophthalmitis in either eye
2. Uncontrolled or symptomatic Dry Eye Syndrome
3. History of Anterior or Posterior Uveitis
4. History of Post injection pain or inflammation with prior treatments
5. Recent thromboembolic event(<3 months)
6. Pregnancy(positive pregnancy test) or Lactation/Premenopausal women not using adequate contraception -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ranibizumab 0.5mg Intravitreal injection; Intravitreal injection of Ranibizumab 0.5mg once	Drug: Ranibizumab 0.5mg; Patient will receive intravitreal injection of Ranibizumab 0.5mg.; Other Names: Lucentis
ACTIVE_COMPARATOR: Aflibercept 2.0mg Intravitreal injection; Intravitreal Aflibercept 2.0mg once	Drug: Aflibercept 2.0mg; Patients will receive intravitreal injection of Aflibercept 2.0mg.; Other Names: Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of Anterior Chamber Inflammation	Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)	24 to 48 hours (visit #1) and 5 to 7 days (visit #2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients With Post Injection Pain Score of One or Higher on Pain Scale	Pain score rated on an 11 point numerical rating from 0-10 ( 0 = no pain, and 10 = worst possible pain) administered to each patient verbally at visit #1 and visit #2. The data below shows number of patients with pain score 1 or greater in each group.	24 to 48 hours (visit #1) and 5 to 7 days (visit #2)

Collaborators and Investigators

• Sponsor: Arshad Khanani
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Arshad M Khanani, MD, Sierra Eye Associates

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (ESTIMATE): August 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 3, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Inflammation; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Aflibercept
• Other Study ID Numbers: ML28895; 20131227 (OTHER: Western Institutional Review Board)