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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.
The investigators will be evaluating patients (1-7 days) post injections for:
1. Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as measured on a standardized pain scale).
This is an open-label, Phase II study of post injection pain and inflammation after intravitreally administered ranibizumab and aflibercept in 100 subjects with Diabetic Macular Edema. Treatment naïve and experienced patients will be enrolled. Treatment experienced patients with history of anti-vegf injections will be eligible as long as they have not received any intravitreal injection in the 3 months prior to the study visit. Patients will be randomized to receive either Lucentis 0.3 mg or Eylea 2.0 mg, and followed for a week. A non-injecting masked physician who is blinded to the treatment drug will evaluate the patient at baseline before the injection and then within 1-2 days and 5-7 days after the injection for anterior chamber and vitreous cells using slit lamp examination and indirect ophthalmoscopy. Pain will also be recorded at these visits using a standardized pain scale.
Consented, enrolled subjects will receive open-label intravitreal injection of either 0.3 mg ranibizumab or 2.0 mg aflibercept. A standard intravitreal injection protocol will be followed. Patients will be revaluated at baseline, 1-2 days and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber and vitreous 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 Nomenculature (SUN) working group classifications. Pain score will be evaluated using a Numerical Rating Scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.3 Intravitreal injection | Active Comparator | Intravitreal injection of Ranibizumab 0.3 mg once |
|
| Aflibercept 2.0 mg intravitreal injection | Active Comparator | Intravitreal Aflibercept 2.0 mg once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.3 mg | Drug | Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intraocular Inflammation | Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam. | 24 to 48 hours (visit #1) |
| Number of Participants With Intraocular Inflammation | Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam | 5 to 7 days (visit #2) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale. | Pain score rated on a 11 point numerical rating from 0-10 administered to each patient verbally at visit #1 and visit #2. 0 = no pain 10 = severe pain | 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 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 0.3 Intravitreal Injection | Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg |
| FG001 | Aflibercept 2.0 mg Intravitreal Injection | Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with diabetic macular edema
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.3 Intravitreal Injection | Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg |
| BG001 | Aflibercept 2.0 mg 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 | Number of Participants With Intraocular Inflammation | Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam. | Posted | Count of Participants | Participants | 24 to 48 hours (visit #1) |
|
7 days
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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 0.3 Intravitreal Injection | Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anterior chamber inflammation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arshad Khanani | Sierra Eye Associates | 775-329-0286 | Arshad.Khanani@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2014 | Nov 4, 2018 | Prot_SAP_000.pdf |
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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 2.0 mg | Drug | Patient will receive intravitreal injection of Aflibercept 2.0 mg |
|
|
Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetic Macular Edema | Diabetic Macular edema as seen on OCT and exam. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Intraocular Inflammation | Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam | Inflammation 5 to 7 days after injection | Posted | Count of Participants | Participants | 5 to 7 days (visit #2) |
|
|
|
| Secondary | Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale. | Pain score rated on a 11 point numerical rating from 0-10 administered to each patient verbally at visit #1 and visit #2. 0 = no pain 10 = severe pain | Posted | Count of Participants | Participants | 24 to 48 hours visit #1 and 5 to 7 days visit #2 |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 6 |
| 51 |
| EG001 | Aflibercept 2.0 mg Intravitreal Injection | Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg | 0 | 50 | 0 | 50 | 10 | 50 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |