Effect of the Adjunctive IVB Before PRP

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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

Official Title
-----------------
Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVB group<br>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. | Drug: bevacizumab<br>* 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<br>* Other names: Avastin; Genentech, Inc., South San Francisco, CA, USA;|
| No Intervention: only PRP group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness | central macular thickness measured by Cirrus HD optical coherence tomography | 6 months after first PRP session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal nerve fiber layer thickness | retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography. | 6 months after first PRP session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
central macular thickness