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

Neovascular Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926977
• Other study ID #: ML28895
• Secondary ID: 20131227
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 19, 2013
• Last updated: February 3, 2016
• Start date: September 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2016
• Source: Sierra Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ranibizumab 0.5mg
Patient will receive intravitreal injection of Ranibizumab 0.5mg.
• Aflibercept 2.0mg
Patients will receive intravitreal injection of Aflibercept 2.0mg.

Locations

Country	Name	City	State
United States	Sierra Eye Associates	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Arshad Khanani	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No