Neovascular Age-Related Macular Degeneration
Conditions
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.
Interventions
Patient will receive intravitreal injection of Ranibizumab 0.5mg.
DRUGAflibercept 2.0mg
Patients will receive intravitreal injection of Aflibercept 2.0mg.
Sponsors
Genentech, Inc.
Arshad Khanani
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Anterior Chamber Inflammation | 24 to 48 hours (visit #1) and 5 to 7 days (visit #2) | Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Post Injection Pain Score of One or Higher on Pain Scale | 24 to 48 hours (visit #1) and 5 to 7 days (visit #2) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab 0.5mg Intravitreal Injection Intravitreal injection of Ranibizumab 0.5mg once
Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg. | 47 |
| Aflibercept 2.0mg Intravitreal Injection Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg. | 53 |
| Total | 100 |
Baseline characteristics
| Characteristic | Ranibizumab 0.5mg Intravitreal Injection | Aflibercept 2.0mg Intravitreal Injection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 47 Participants | 53 Participants | 100 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 76.3 years | 80.6 years | 78.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 48 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 46 Participants | 52 Participants | 98 Participants |
| Region of Enrollment United States | 47 participants | 53 participants | 100 participants |
| Sex: Female, Male Female | 26 Participants | 34 Participants | 60 Participants |
| Sex: Female, Male Male | 21 Participants | 19 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 47 | 10 / 53 |
| serious Total, serious adverse events | 0 / 47 | 0 / 53 |
Outcome results
Primary
Evidence of Anterior Chamber Inflammation
Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)
Time frame: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5mg Intravitreal Injection | Evidence of Anterior Chamber Inflammation | Inflammation at visit 1 | 1 participants |
| Ranibizumab 0.5mg Intravitreal Injection | Evidence of Anterior Chamber Inflammation | Inflammation at visit 2 | 0 participants |
| Aflibercept 2.0mg Intravitreal Injection | Evidence of Anterior Chamber Inflammation | Inflammation at visit 1 | 10 participants |
| Aflibercept 2.0mg Intravitreal Injection | Evidence of Anterior Chamber Inflammation | Inflammation at visit 2 | 1 participants |
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.
Time frame: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5mg Intravitreal Injection | Patients With Post Injection Pain Score of One or Higher on Pain Scale | Subjects with pain score 1 or higher at visit 1 | 7 participants |
| Ranibizumab 0.5mg Intravitreal Injection | Patients With Post Injection Pain Score of One or Higher on Pain Scale | Subjects with pain score 1 or higher at visit 2 | 0 participants |
| Aflibercept 2.0mg Intravitreal Injection | Patients With Post Injection Pain Score of One or Higher on Pain Scale | Subjects with pain score 1 or higher at visit 1 | 9 participants |
| Aflibercept 2.0mg Intravitreal Injection | Patients With Post Injection Pain Score of One or Higher on Pain Scale | Subjects with pain score 1 or higher at visit 2 | 1 participants |