A Phase 2 interventional study of Intravitreal Aflibercept Injection and Standard Vitrectomy in Vitreous Hemorrhage, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by University of Oklahoma · Phase 2, Interventional, and Treatment
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.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Drug: Intravitreal Aflibercept Injection
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Other: Standard Vitrectomy
One time 2.0mg aflibercept injection, following pars plana vitrectomy.
Also known as: Eylea
Surgical intervention
Rate of Resolved Post-operative Vitreous Hemorrhage.
Percentage of patients who had no vitreous hemorrhage before or at week 24
Time frame: 24 weeks
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
Need for Any Additional Surgical Intervention.
Time frame: 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.
Time frame: 24 weeks
| Milestone | Vitrectomy With Aflibercept Injection | Standard Vitrectomy |
|---|---|---|
| Started | 6 | 6 |
| Completed | 4 | 3 |
| Not completed | 2 | 3 |
Percentage of patients who had no vitreous hemorrhage before or at week 24
| Participants | Vitrectomy With Aflibercept Injection | Standard Vitrectomy |
|---|---|---|
| Rate of Resolved Post-operative Vitreous Hemorrhage. | 6 | 5 |
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.
| Number of letters Read | Vitrectomy With Aflibercept Injection | Standard Vitrectomy |
|---|---|---|
| Mean Change in Visual Acuity | 56.75 (0 to 100) | 41.67 (0 to 100) |
| Participants | Vitrectomy With Aflibercept Injection | Standard Vitrectomy |
|---|---|---|
| Need for Any Additional Surgical Intervention. | 0 | 0 |
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.
| Microns | Vitrectomy With Aflibercept Injection | Standard Vitrectomy |
|---|---|---|
| Changes in Mean Central Retinal Thickness. | — | 20 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitrectomy With Aflibercept Injection | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Standard Vitrectomy | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Event | Vitrectomy With Aflibercept Injection | Standard Vitrectomy |
|---|---|---|
| Post operative ocular painEye disorders | 3/6 | 4/6 |
| HeadacheGeneral disorders | 1/6 | 3/6 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 0/6 | 2/6 |
| Subconjunctival HemorrhageEye disorders | 2/6 | 1/6 |
| NauseaGastrointestinal disorders | 2/6 | 0/6 |
| Broken RibMusculoskeletal and connective tissue disorders | 0/6 | 1/6 |
| descemet's foldsEye disorders | 0/6 | 1/6 |
| vitreous hazeEye disorders | 1/6 | 0/6 |
| cataractEye disorders | 0/6 | 1/6 |
| Optic disc pallorEye disorders | 0/6 | 1/6 |
| Age, Categorical(Participants) | Vitrectomy With Aflibercept Injection | Standard Vitrectomy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 5 | 11 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Vitrectomy With Aflibercept Injection | Standard Vitrectomy | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 3 | 4 | 7 |
| Race (NIH/OMB)(Participants) | Vitrectomy With Aflibercept Injection | Standard Vitrectomy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 4 | 5 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vitrectomy With Aflibercept Injection | Standard Vitrectomy | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
| Mean visual acuity(number of letters read on ETDRS Chart) | Vitrectomy With Aflibercept Injection | Standard Vitrectomy | Total |
|---|---|---|---|
| Mean | 13.8 (0 to 100) | 17.7 (0 to 100) | 15.9 (0 to 100) |
| Intraocular pressure(mmHg) | Vitrectomy With Aflibercept Injection | Standard Vitrectomy | Total |
|---|---|---|---|
| Mean | 14 (10 to 18) | 11.2 (6 to 18) | 12.6 (6 to 18) |
| Central retinal thickness(Microns) | Vitrectomy With Aflibercept Injection | Standard Vitrectomy | Total |
|---|---|---|---|
| Mean | 304 (304 to 304) | 305 (305 to 305) | 304.5 (304 to 305) |
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University of Oklahoma