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

NCT ID: NCT01926977

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-05-31

Brief Summary

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

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.

Conditions

Neovascular Age-Related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ranibizumab 0.5mg Intravitreal injection

Intravitreal injection of Ranibizumab 0.5mg once

Group Type: ACTIVE_COMPARATOR

Ranibizumab 0.5mg

Intervention Type: DRUG

Patient will receive intravitreal injection of Ranibizumab 0.5mg.

Aflibercept 2.0mg Intravitreal injection

Intravitreal Aflibercept 2.0mg once

Group Type: ACTIVE_COMPARATOR

Aflibercept 2.0mg

Intervention Type: DRUG

Patients will receive intravitreal injection of Aflibercept 2.0mg.

Interventions

Ranibizumab 0.5mg

Patient will receive intravitreal injection of Ranibizumab 0.5mg.

Intervention Type: DRUG

Aflibercept 2.0mg

Patients will receive intravitreal injection of Aflibercept 2.0mg.

Intervention Type: DRUG

Other Intervention Names

Lucentis; Eylea

Eligibility Criteria

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 -

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Arshad Khanani

OTHER

Sponsor Role: lead

Responsible Party

Arshad Khanani

Vitreo-Retinal Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arshad M Khanani, MD

Role: PRINCIPAL_INVESTIGATOR

Sierra Eye Associates

Locations

Sierra Eye Associates

Reno, Nevada, United States

Countries

United States

Other Identifiers

20131227

Identifier Type: OTHER

Identifier Source: secondary_id

ML28895

Identifier Type: -

Identifier Source: org_study_id