Bevacizumab as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

NCT01389505 | Unknown Phase 2

• 1 other identifier: CONEP16249
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized and comparative study is to quantify the functional and structural alterations of the macula in patients with proliferative Diabetic Retinopathy submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab as a adjuvant therapy in preventing the adverse events of that procedure. The patients with proliferative Diabetic Retinopathy (DR) with indication of binocular laser photocoagulation will be examined by ophthalmologists who will measure the visual acuity and contrast sensitivity, perform slit lamp examination, fundus examination and optic coherence tomography before and after laser photocoagulation. Laser photocoagulation will be performed in both eyes according Early Treatment Diabetic Retinopathy Study that advocate the realization of 3 episodes of laser photocoagulation in 3 weeks. This comparative study analyses the effect of intravitreal bevacizumab one week before laser photocoagulation and one, three and six months after the randomization visit. The fellow eye will be submitted only to laser photocoagulation and will be considered as control. It is estimated a sample of 30 patients. All procedures, purposes and methods will be explained to all patients.

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy; Bevacizumab; Panretinal Photocoagulation

Outcome Measures

Primary Outcomes (1)

• Functional Macular Evaluation

  During this 24 weeks of follow-up the Visual acuity (ETDRS), Contrast vision will be measured at baseline, 4, 12 and finally at 24 week

  24 weeks

Secondary Outcomes (1)

• Structural Macular Evaluation

  24 weeks

Study Arms (2)

Panretinal photocoagulation

ACTIVE COMPARATOR

Group 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3.

Procedure: Panretinal photocoagulation

Bevacizumab + Panretinal Photocoagulation (PRP)

EXPERIMENTAL

Group 2: Bevacizumab intravitreous injections plus PRP

Procedure: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab

Interventions

Panretinal photocoagulation PROCEDURE

Three episodes of panretinal photocoagulation with one week of interval

Panretinal photocoagulation

Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab PROCEDURE

Intravitreous injection of Bevacizumab 1 week before and the other at the same day of the third episode of PRP

Bevacizumab + Panretinal Photocoagulation (PRP)

Eligibility Criteria

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

You may qualify if:

• Proliferative diabetic retinopathy eyes.
• Best Corrected-Visual Acuity at baseline \> 20/320 in the study eye.
• Patients with and without diabetic macular edema
• Type II diabetic subjects as defined by the World Health Organization
• aged ≥ 18 years.
• Women must be using effective contraception
• Ability to provide written informed consent.
• Indication of panretinal photocoagulation in both eyes

You may not qualify if:

• Vitreous hemorrhage or pre-retinal hemorrhage
• Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months.
• Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
• Cataract
• Any intraocular surgery within 6 months before trial enrollment.
• Previous vitrectomy.
• Any of the following underlying systemic diseases:
• History or evidence of severe cardiac disease or previous thrombus-embolic event

Sponsors & Collaborators

• Instituto do Coracao: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (2)

• Preti RC, Mutti A, Ferraz DA, Zacharias LC, Nakashima Y, Takahashi WY, Monteiro ML. The effect of laser pan-retinal photocoagulation with or without intravitreal bevacizumab injections on the OCT-measured macular choroidal thickness of eyes with proliferative diabetic retinopathy. Clinics (Sao Paulo). 2017 Feb 1;72(2):81-86. doi: 10.6061/clinics/2017(02)03.

  PMID: 28273240 DERIVED

• Preti RC, Ramirez LM, Monteiro ML, Carra MK, Pelayes DE, Takahashi WY. Contrast sensitivity evaluation in high risk proliferative diabetic retinopathy treated with panretinal photocoagulation associated or not with intravitreal bevacizumab injections: a randomised clinical trial. Br J Ophthalmol. 2013 Jul;97(7):885-9. doi: 10.1136/bjophthalmol-2012-302675. Epub 2013 May 17.

  PMID: 23686001 DERIVED

Study Officials

• Walter Y Takahashi, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rony C Preti, MD

CONTACT

+551199991636; rypreti@hotmail.com

University Sao Paulo

CONTACT

+551130696000

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 8, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 8, 2011

Record last verified: 2011-01

Locations

BR (1)