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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Instituto do Coracao.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Instituto do Coracao
ClinicalTrials.gov Identifier:
NCT01389505
First received: July 5, 2011
Last updated: July 7, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Proliferative Diabetic Retinopathy
Procedure: Panretinal photocoagulation
Procedure: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Structural and Functional Evaluation of the Macula in Patients With Proliferative Diabetic Retinopathy Treated With Panretinal Photocoagulation and Bevacizumab (Avastin ®)

Resource links provided by NLM:


Further study details as provided by Instituto do Coracao:

Primary Outcome Measures:
  • Functional Macular Evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Structural Macular Evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    During the 24 weeks of follow-up the following measured will be made: Optical coherence tomography, need of vitrectomy, need panretianal photocoagulation retreatment, adverse events, recurrence of neovascularizaton, need or additional focal and grid macular laser for diabetic macular edema


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Panretinal photocoagulation
Group 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3.
Procedure: Panretinal photocoagulation
Three episodes of panretinal photocoagulation with one week of interval
Experimental: Bevacizumab + Panretinal Photocoagulation (PRP)
Group 2: Bevacizumab intravitreous injections plus PRP
Procedure: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab
Intravitreous injection of Bevacizumab 1 week before and the other at the same day of the third episode of PRP

Detailed Description:

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. Therefore this study is designed using both treatments in the same patient: intravitreal Bevacizumab plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. These patients had their visual acuity and contrast vision measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography.

Patients with similar proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and intravitreal Bevacizumab injections in one eye. For the Bevacizumab injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. Patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. Patients whose condition does not improve may undergo new evaluation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389505

Contacts
Contact: Rony C Preti, MD +551199991636 rypreti@hotmail.com
Contact: University Sao Paulo +551130696000

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Rony C Preti, MD    +551199991636    rypreti@hotmail.com   
Sub-Investigator: Rony C Preti, MD         
Sponsors and Collaborators
Instituto do Coracao
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Walter Y Takahashi, PhD University of Sao Paulo
  More Information

No publications provided by Instituto do Coracao

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Sao Paulo, Faculdade de Medicina da Universidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT01389505     History of Changes
Other Study ID Numbers: CONEP16249, CONEP16249
Study First Received: July 5, 2011
Last Updated: July 7, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Coracao:
Proliferative Diabetic Retinopathy
Bevacizumab
Panretinal Photocoagulation

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014