- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01805297
Aflibercept Injection for Proliferative Diabetic Retinopathy
December 8, 2023 updated by: University of Oklahoma
Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Dean McGee Eye Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vitrectomy with Aflibercept Injection
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
|
One time 2.0mg aflibercept injection, following pars plana vitrectomy.
Other Names:
|
Active Comparator: Standard Vitrectomy
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
|
Surgical intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Resolved Post-operative Vitreous Hemorrhage.
Time Frame: 24 weeks
|
Percentage of patients who had no vitreous hemorrhage before or at week 24
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Visual Acuity
Time Frame: 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.
|
24 weeks
|
Need for Any Additional Surgical Intervention.
Time Frame: 24 weeks
|
24 weeks
|
|
Changes in Mean Central Retinal Thickness.
Time Frame: 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.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert E Leonard, MD, Dean McGee Eye Institute
- Principal Investigator: Vinay A Shah, MD, Dean McGee Eye Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
February 26, 2013
First Submitted That Met QC Criteria
March 4, 2013
First Posted (Estimated)
March 6, 2013
Study Record Updates
Last Update Posted (Estimated)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Eye Hemorrhage
- Retinal Diseases
- Diabetic Retinopathy
- Hemorrhage
- Vitreous Hemorrhage
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Aflibercept
Other Study ID Numbers
- 2148 (Inselspital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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