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To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitrectomy with Aflibercept Injection | Active Comparator | Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection. |
|
| Standard Vitrectomy | Active Comparator | Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Aflibercept Injection | Drug | One time 2.0mg aflibercept injection, following pars plana vitrectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Resolved Post-operative Vitreous Hemorrhage. | Percentage of patients who had no vitreous hemorrhage before or at week 24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity | Change in visual acuity measured using "Early Treatment of Diabetic Retinopathy Study" visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert E Leonard, MD | Dean McGee Eye Institute | Principal Investigator |
| Vinay A Shah, MD | Dean McGee Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37260074 | Derived | Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitrectomy With Aflibercept Injection | Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection. Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy. |
| FG001 | Standard Vitrectomy | Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy. Standard Vitrectomy: Surgical intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitrectomy With Aflibercept Injection | Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection. Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, immediately following pars plana vitrectomy. |
| BG001 |
| 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 | Rate of Resolved Post-operative Vitreous Hemorrhage. | Percentage of patients who had no vitreous hemorrhage before or at week 24 | Posted | Count of Participants | Participants | 24 weeks |
|
6 months
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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 | Vitrectomy With Aflibercept Injection | Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection. Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert E. Leonard, II, MD | Dean McGee Eye Institute | 405-271-6060 | sonny-icks@dmei.org |
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| ID | Term |
|---|---|
| D014823 | Vitreous Hemorrhage |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Standard Vitrectomy | Other | Surgical intervention |
|
| Need for Any Additional Surgical Intervention. |
| 24 weeks |
| Changes in Mean Central Retinal Thickness. | The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness. | 24 weeks |
| Standard Vitrectomy |
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy. Standard Vitrectomy: Surgical intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean visual acuity | Number of letters read on the "Early Treatment Diabetic Retinopathy Study" visual acuity chart. a higher number indicates a better visual acuity (example, 0 means no letters could be read while 100 means all 100 letters present on chart were read) | Mean | Full Range | number of letters read on ETDRS Chart |
|
| Intraocular pressure | Mean | Full Range | mmHg |
|
| Central retinal thickness | Optical Coherence Tomography performed only as visualization permitted | Mean | Full Range | Microns |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean Change in Visual Acuity | Change in visual acuity measured using "Early Treatment of Diabetic Retinopathy Study" visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased. | Patients who completed 24 week visit | Posted | Mean | Full Range | Number of letters Read | 24 weeks |
|
|
|
| Secondary | Need for Any Additional Surgical Intervention. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Changes in Mean Central Retinal Thickness. | The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness. | Due to lack of clear view due to vitreous Hemorrhage, all but 2 patients were unable to have optical coherence tomography at baseline, and one these was lost to follow up. For this reason, data collected for the few patients who were able to have the test was not analyzed | Posted | Number | Microns | 24 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Standard Vitrectomy | Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy. Standard Vitrectomy: Surgical intervention | 0 | 6 | 0 | 6 | 5 | 6 |
| Broken Rib | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Post operative ocular pain | Eye disorders | Non-systematic Assessment | pain after vitrectomy surgery |
|
| descemet's folds | Eye disorders | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Subconjunctival Hemorrhage | Eye disorders | Non-systematic Assessment | sub conjunctival hemorrhage occurring post treatment |
|
| vitreous haze | Eye disorders | Non-systematic Assessment | vitreous haze occurring in non-study eye |
|
| cataract | Eye disorders | Non-systematic Assessment | worsening of cataract post operatively |
|
| Optic disc pallor | Eye disorders | Non-systematic Assessment | observed on clinical exam |
|
| visual disturbance | Eye disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | post operative nausea |
|
| vitreous hemorrhage | Eye disorders | Non-systematic Assessment | seen in non study eye on clinical exam |
|
| photophobia | Eye disorders | Non-systematic Assessment |
|
| tooth decay | General disorders | Non-systematic Assessment |
|
| tongue injury | General disorders | Non-systematic Assessment | patient reported biting and injuring tongue |
|
| ocular irritation | Eye disorders | Non-systematic Assessment | patient reported ocular irritation post operatively |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|