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Effect of the Adjunctive IVB Before PRP

NCT ID: NCT01504724

Last Updated: 2013-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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This prospective randomized study included 30 patients (60 eyes) with severe nonproliferative diabetic retinopathy or non-high-risk proliferative diabetic retinopathy. They had weekly PRP treatments in 3 sessions and they were randomly assigned to IVB group who had adjunctive IVB within 1 week before first PRP and control group who had only PRP. CMT, RNFL, and best-corrected visual acuity (BCVA) were measured

Conditions

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Diabetic Retinopathy

Keywords

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central macular thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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bevacizumab

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

Intervention Type DRUG

Other Intervention Names

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Avastin; Genentech, Inc., South San Francisco, CA, USA

Eligibility Criteria

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Inclusion Criteria

* patients with severe NPDR or early PDR without macular edema
* best-corrected visual acuity (BCVA) of 20/25 or better
* patients who were followed up for at least 6 months after the first PRP.

Exclusion Criteria

* patients with retinal or choroidal diseases except diabetic retinopathy
* contraindications to fluorescein angiography (FA) or bevacizumab
* patients who had previous treatments including anti-angiogenic medications and laser photocoagulation
* patients with previous vitrectomy
* patients with uncontrolled hypertension, a recent myocardial infarction or cerebral vascular accidents.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Ho Park

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Ho Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Dong Ho Park

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Jo YJ, Heo DW, Shin YI, Kim JY. Diurnal variation of retina thickness measured with time domain and spectral domain optical coherence tomography in healthy subjects. Invest Ophthalmol Vis Sci. 2011 Aug 17;52(9):6497-500. doi: 10.1167/iovs.11-7403.

Reference Type BACKGROUND
PMID: 21705686 (View on PubMed)

Other Identifiers

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IVB and PRP

Identifier Type: -

Identifier Source: org_study_id