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

Arshad Khanani

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: Ranibizumab 0.5mg; Drug: Aflibercept 2.0mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01926977

ML28895

20131227 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Ranibizumab 0.5mg Intravitreal injection

Active Comparator group

Description:

Intravitreal injection of Ranibizumab 0.5mg once

Treatment:

Drug: Ranibizumab 0.5mg

Aflibercept 2.0mg Intravitreal injection

Active Comparator group

Description:

Intravitreal Aflibercept 2.0mg once

Treatment:

Drug: Aflibercept 2.0mg