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

Sponsor
Panhandle Eye Group, LLP
Study ID
NCT02590094
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 31, 2015
Status verified
Nov 2021
Primary completion
Jan 4, 2019
Completion
Jan 4, 2019

Study Design

Enrollment
568 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
    Study Group A: Subjects receive 2.5 mg intravitreal bevacizumab 1-3 days prior to vitrectomy.
  • Active Comparator: B
    Study Group B: Subjects receive 2.5 mg intravitreal bevacizumab 5-10 days prior to vitrectomy.
  • Active Comparator: C
    Study Group C: Subjects receive 1.25 mg intravitreal bevacizumab 1-10 days prior to vitrectomy.
  • Active Comparator: D
    Study Group D: Subjects receive 0.625 mg intravitreal bevacizumab 1-10 days prior to vitrectomy.
  • Active Comparator: E
    Study Group E: Subjects receive 2.5 mg intravitreal bevacizumab 1-10 days prior to vitrectomy.
  • Active Comparator: F
    Study Group F: Subjects receive 1.25 mg intravitreal ziv-aflibercept 1-10 days prior to vitrectomy.
  • Active Comparator: G
    Study Group G: Subjects receive 1.25 mg intravitreal ziv-aflibercept 1-3 days prior to vitrectomy.
  • Active Comparator: H
    Study Group H: Subjects receive 1.25 mg intravitreal ziv-aflibercept 5-10 days prior to vitrectomy.
  • Active Comparator: I
    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.

Primary Outcome Measure

Visual Acuity [ Time Frame: 6 months ]

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