Phase 2
Completed N=12
Aflibercept Injection for Proliferative Diabetic Retinopathy
Vitreous Hemorrhage
Source: ClinicalTrials.gov NCT01805297 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Rate of Resolved Post-operative Vitreous Hemorrhage. — 6; 5 Participants
Summary
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Resolved Post-operative Vitreous Hemorrhage. |
6; 5 | — |
| SECONDARY Mean Change in Visual Acuity |
56.75; 41.67 | — |
| SECONDARY Need for Any Additional Surgical Intervention. |
0; 0 | — |
| SECONDARY Changes in Mean Central Retinal Thickness. |
20 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01805297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.