Effect of the Adjunctive IVB Before PRP

Sponsor
Kyungpook National University Hospital
Study ID
NCT01504724
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    intravitreal bevacizumab injection (1.25 mg/0.05 mL) was done 4.0 mm posterior to the corneal limbus using a 30-gauge needle after topical anesthesia

Study Details

This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without macular edema.

Key Dates

First listed
Jan 5, 2012
Start date
Aug 31, 2011
Status verified
Dec 2013
Primary completion
Aug 31, 2012
Completion
Aug 31, 2013

Study Design

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

Arms

  • Experimental: IVB group
    Patients were treated with IVB injections approximately within 1 week before the first PRP. Then patients had PRP, which was done in three sessions at weeks 0, 1, and 2 according to ETDRS guidelines. The superior, inferior, and nasal and temporal areas were treated sequentially.
  • No Intervention: only PRP group
    Patients had PRP, which was done in three sessions at weeks 0, 1, and 2 according to ETDRS guidelines. The superior, inferior, and nasal and temporal areas were treated sequentially.

Primary Outcome Measure

Central macular thickness [ Time Frame: 6 months after first PRP session ]

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