Vitreous Hemorrhage
Conditions
Keywords
Proliferative Diabetic Retinopathy
Brief summary
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
Detailed description
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.
Interventions
One time 2.0mg aflibercept injection, following pars plana vitrectomy.
OTHERStandard Vitrectomy
Surgical intervention
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 18 years * Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana vitrectomy (PPV) * Best corrected visual acuity in the study eye between 20/40 to light perception (LP) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Exclusion criteria
* Pregnancy (positive urine pregnancy test) or lactation * Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch. * Participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study * For previously treated subjects - * Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye within 28 days of Screening * Prior treatment with triamcinolone in the study eye within 6 months of Screening. * Prior treatment with dexamethasone in the study eye within 30 days of Screening * Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline * History of vitrectomy surgery, submacular surgery, or other surgical intervention for PDR in the study eye * Active intraocular inflammation (grade trace or above) in the study eye * History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 30 mmHg despite treatment with anti-glaucoma medication) * History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment. * History of allergy to fluorescein, indocyanine green (ICG) or iodine, not amenable to treatment * Presence of macular traction * Uncontrolled hypertension (e.g., 120/200 mmHg) prior to surgery (PPV) * Concomitant use of any systemic anti-VEGF therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Resolved Post-operative Vitreous Hemorrhage. | 24 weeks | Percentage of patients who had no vitreous hemorrhage before or at week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Visual Acuity | 24 weeks | 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. |
| Need for Any Additional Surgical Intervention. | 24 weeks | — |
| Changes in Mean Central Retinal Thickness. | 24 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Standard Vitrectomy Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Standard Vitrectomy: Surgical intervention | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Vitrectomy With Aflibercept Injection | Standard Vitrectomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Central retinal thickness | 304 Microns | 305 Microns | 304.5 Microns |
| Intraocular pressure | 14 mmHg | 11.2 mmHg | 12.6 mmHg |
| Mean visual acuity | 13.8 number of letters read on ETDRS Chart | 17.7 number of letters read on ETDRS Chart | 15.9 number of letters read on ETDRS Chart |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 9 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 6 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Rate of Resolved Post-operative Vitreous Hemorrhage.
Percentage of patients who had no vitreous hemorrhage before or at week 24
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitrectomy With Aflibercept Injection | Rate of Resolved Post-operative Vitreous Hemorrhage. | 6 Participants |
| Standard Vitrectomy | Rate of Resolved Post-operative Vitreous Hemorrhage. | 5 Participants |
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.
Time frame: 24 weeks
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Vitrectomy | Changes in Mean Central Retinal Thickness. | 20 Microns |
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.
Time frame: 24 weeks
Population: Patients who completed 24 week visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitrectomy With Aflibercept Injection | Mean Change in Visual Acuity | 56.75 Number of letters Read |
| Standard Vitrectomy | Mean Change in Visual Acuity | 41.67 Number of letters Read |
Secondary
Need for Any Additional Surgical Intervention.
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitrectomy With Aflibercept Injection | Need for Any Additional Surgical Intervention. | 0 Participants |
| Standard Vitrectomy | Need for Any Additional Surgical Intervention. | 0 Participants |