Preoperative Bevacizumab and Ziv-Aflibercept Administration in PDR Subjects Undergoing PPV

NCT02590094 | Completed DMC

• 1 other identifier: 4
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 1

Brief Summary

To compare outcomes in subjects receiving different doses and treatment intervals of intravitreal bevacizumab or ziv-aflibercept preoperatively administered prior to undergoing vitrectomy for complications of proliferative diabetic retinopathy.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Change in BCSVA from baseline

  6 months

Secondary Outcomes (2)

• Complications

  6 months

• Time

  1 day

Study Arms (9)

A

ACTIVE COMPARATOR

Study Group A: Subjects receive 2.5 mg intravitreal bevacizumab 1-3 days prior to vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

B

ACTIVE COMPARATOR

Study Group B: Subjects receive 2.5 mg intravitreal bevacizumab 5-10 days prior to vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

C

ACTIVE COMPARATOR

Study Group C: Subjects receive 1.25 mg intravitreal bevacizumab 1-10 days prior to vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

D

ACTIVE COMPARATOR

Study Group D: Subjects receive 0.625 mg intravitreal bevacizumab 1-10 days prior to vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

E

ACTIVE COMPARATOR

Study Group E: Subjects receive 2.5 mg intravitreal bevacizumab 1-10 days prior to vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

F

ACTIVE COMPARATOR

Study Group F: Subjects receive 1.25 mg intravitreal ziv-aflibercept 1-10 days prior to vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

G

ACTIVE COMPARATOR

Study Group G: Subjects receive 1.25 mg intravitreal ziv-aflibercept 1-3 days prior to vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

H

ACTIVE COMPARATOR

Study Group H: Subjects receive 1.25 mg intravitreal ziv-aflibercept 5-10 days prior to vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

I

ACTIVE COMPARATOR

Study Group I: Subjects receive 1.25 mg intravitreal ziv-aflibercept 1-10 days prior to vitrectomy, and then receive 1.25 mg intravitreal ziv-aflibercept at the completion of the vitrectomy.

Drug: Intravitreal bevacizumab or intravitreal ziv-aflibercept

Interventions

Intravitreal bevacizumab or intravitreal ziv-aflibercept DRUG

Intravitreal bevacizumab or intravitreal ziv-aflibercept is given preoperatively at various time intervals and doses.

A; B; C; D; E; F; G; H; I

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age is 18-85 years.
• Subject consents to study participation and is capable of 6 months of follow-up.
• The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
• Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to light perception with projection in the study eye.
• The subject is determined to need a PPV because of reduced BCSVA principally from a non-clearing vitreous hemorrhage, TRD, fibrous proliferation, or a combination of the three. When non-clearing vitreous hemorrhage is the principal reason for PPV, the hemorrhage must have been present by subjective history for at least 3 months. When TRD is the principal reason for PPV, the TRD must be threatening (within one disc diameter) or involving the fovea. When fibrovascular proliferation is the principal reason for PPV, it must be extensive (\>3 clock hours) and threatening (within one disc diameter) or involving the fovea.
• Only one eye per patient is eligible for the study.

You may not qualify if:

• Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
• Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
• Subject has a significant corneal opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
• Subject is known to have had a macula-involving retinal detachment for greater than 6 months in the study eye.
• Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
• Subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmHg despite medical/surgical treatment) in the study eye.
• Subject received systemic or intravitreal anti-VEGF treatment to the study eye within 3 months of anticipated study enrollment.
• Subject has uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.

Sponsors & Collaborators

• Panhandle Eye Group, LLP: lead

Study Sites (1)

Hospital La Carlota

Montemorelos, Nuevo León, Mexico

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Sloan Rush, MD

  panhandle eye group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: January 4, 2019
• Study Completion: January 4, 2019
• Last Updated: December 3, 2021

Record last verified: 2021-11

Locations

ME (1)