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| ID | Type | Description | Link |
|---|---|---|---|
| 20131227 | Other Identifier | Western Institutional Review Board |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5mg Intravitreal injection | Active Comparator | Intravitreal injection of Ranibizumab 0.5mg once |
|
| Aflibercept 2.0mg Intravitreal injection | Active Comparator | Intravitreal Aflibercept 2.0mg once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.5mg | Drug | Patient will receive intravitreal injection of Ranibizumab 0.5mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arshad M Khanani, MD | Sierra Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab 0.5mg Intravitreal Injection | Intravitreal injection of Ranibizumab 0.5mg once Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg. |
| FG001 | Aflibercept 2.0mg Intravitreal Injection | Intravitreal Aflibercept 2.0mg once Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.5mg Intravitreal Injection | Intravitreal injection of Ranibizumab 0.5mg once Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg. |
| BG001 | Aflibercept 2.0mg Intravitreal Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evidence of Anterior Chamber Inflammation | Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN) | Posted | Number | participants | 24 to 48 hours (visit #1) and 5 to 7 days (visit #2) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranibizumab 0.5mg Intravitreal Injection | Intravitreal injection of Ranibizumab 0.5mg once Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber inflammation at Visit 1 | Eye disorders | Non-systematic Assessment | All patients in this group had 0.5+ inflammation as reported using Standardization of Uveitis Nomenculature working group classification. |
Small sample size. Non-randomized choice of medications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arshad Khanani M.D., Vitreo-Retinal Diseases and Surgery | Sierra Eye Associates | 775-329-0286 | arshad.khanani@gmail.com |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Aflibercept 2.0mg | Drug | Patients will receive intravitreal injection of Aflibercept 2.0mg. |
|
|
Intravitreal Aflibercept 2.0mg once
Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| 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. | Posted | Number | participants | 24 to 48 hours (visit #1) and 5 to 7 days (visit #2) |
|
|
|
| 0 |
| 47 |
| 1 |
| 47 |
| EG001 | Aflibercept 2.0mg Intravitreal Injection | Intravitreal Aflibercept 2.0mg once Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg. | 0 | 53 | 10 | 53 |
|
| Anterior chamber inflammation at Visit 2 | Eye disorders | Patient had 1+ inflammation as reported using Standardization of Uveitis Nomenculature working group classification. |
|
| Vitreous inflammation at Visit 1 | Eye disorders | Inflammation was mild and was graded as 0.5 on Nussenblatt scale |
|
| Vitreous inflammation at Visit 2 | Eye disorders | Inflammation was mild and was graded as 0.5 on Nussenblatt scale |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |