Intravitreal Bevacizumab vs Photocoagulation for Proliferative Diabetic Retinopathy

NCT ID: NCT00347698

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-08-31

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.

Detailed Description

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

intravitreal injection of bevacizumab

Intervention Type: DRUG

panretinal photocoagulation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• symmetric proliferative diabetic retinopathy without high risk characteristics
• age 18 years or older
• patient consent

Exclusion Criteria

• heart attack or cerebrovascular attack
• only eye
• retinal detachment
• vitreous haemorrhage
• previous treatment for diabetic retinopathy
• media opacities that preclude visualization of the fundus
• pregnancy
• inability to understands the implications of the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role: lead

Principal Investigators

Gerardo García-Aguirre, MD

Role: PRINCIPAL_INVESTIGATOR

Asociación para Evitar la Ceguera en México

Locations

Asociación para Evitar la Ceguera en México

Mexico City, D. F, Mexico

Countries

Mexico

References

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Reference Type: BACKGROUND

PMID: 3658348 (View on PubMed)

Frank RN. Visual fields and electroretinography following extensive photocoagulation. Arch Ophthalmol. 1975 Aug;93(8):591-8. doi: 10.1001/archopht.1975.01010020575004.

Reference Type: BACKGROUND

PMID: 1171677 (View on PubMed)

Salti H. Visual dysfunction after panretinal photocoagulation in patients with severe diabetic retinopathy and good vision. Am J Ophthalmol. 2006 Feb;141(2):422; author reply 422-3. doi: 10.1016/j.ajo.2005.10.040. No abstract available.

Reference Type: BACKGROUND

PMID: 16458724 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12597922 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 9377574 (View on PubMed)

Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. doi: 10.1097/00006982-200603000-00004.

Reference Type: BACKGROUND

PMID: 16508426 (View on PubMed)

Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. doi: 10.1097/00006982-200603000-00016. No abstract available.

Reference Type: BACKGROUND

PMID: 16508438 (View on PubMed)

Iturralde D, Spaide RF, Meyerle CB, Klancnik JM, Yannuzzi LA, Fisher YL, Sorenson J, Slakter JS, Freund KB, Cooney M, Fine HF. Intravitreal bevacizumab (Avastin) treatment of macular edema in central retinal vein occlusion: a short-term study. Retina. 2006 Mar;26(3):279-84. doi: 10.1097/00006982-200603000-00005.

Reference Type: BACKGROUND

PMID: 16508427 (View on PubMed)

Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5.

Reference Type: BACKGROUND

PMID: 16156152 (View on PubMed)

Rosenfeld PJ, Fung AE, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for macular edema from central retinal vein occlusion. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):336-9.

Reference Type: BACKGROUND

PMID: 16156153 (View on PubMed)

Other Identifiers

APEC-007

Identifier Type: -

Identifier Source: org_study_id