Clinical trial NCT01926977: Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration
Official title: Evaluation of Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-Related Macular Degeneration
Lead sponsor: Sierra Eye Associates
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2013-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: Evidence of Anterior Chamber Inflammation
timeFrame: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)
Secondary outcomes:
measure: Patients With Post Injection Pain Score of One or Higher on Pain Scale
timeFrame: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)
Other outcomes:
Locations:
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
Study officials:
affiliation: Sierra Eye Associates
name: Arshad M Khanani, MD
role: PRINCIPAL_INVESTIGATOR
References: