MedDataX Logo

Aflibercept Injection for Proliferative Diabetic Retinopathy

NCT ID: NCT01805297

Last Updated: 2023-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitreous Hemorrhage

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Proliferative Diabetic Retinopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitrectomy with Aflibercept Injection

Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.

Group Type ACTIVE_COMPARATOR

Intravitreal Aflibercept Injection

Intervention Type DRUG

One time 2.0mg aflibercept injection, following pars plana vitrectomy.

Standard Vitrectomy

Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.

Group Type ACTIVE_COMPARATOR

Standard Vitrectomy

Intervention Type OTHER

Surgical intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravitreal Aflibercept Injection

One time 2.0mg aflibercept injection, following pars plana vitrectomy.

Intervention Type DRUG

Standard Vitrectomy

Surgical intervention

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eylea

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert E Leonard, MD

Role: PRINCIPAL_INVESTIGATOR

Dean McGee Eye Institute

Vinay A Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Dean McGee Eye Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dean McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37260074 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2148

Identifier Type: -

Identifier Source: org_study_id