Clinical trial NCT00347698: Intravitreal Bevacizumab vs Photocoagulation for Proliferative Diabetic Retinopathy
Official title: Intravitreal Bevacizumab vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-year Prospective, Contralateral Eye Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy
bevacizumab
photocoagulation
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Best corrected visual acuity at six months and one year
measure: Macular thickness measured by OCT at six months and one year
measure: Median deviation in visual fields at one year
measure: Score on a patient satisfaction scale at six months and one year
Secondary outcomes:
measure: Complications associated to each treatment
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación para Evitar la Ceguera en México
state: D. F
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Gerardo García-Aguirre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1987 Jul;94(7):761-74. doi: 10.1016/s0161-6420(87)33527-4.
citation: Frank RN. Visual fields and electroretinography following extensive photocoagulation. Arch Ophthalmol. 1975 Aug;93(8):591-8. doi: 10.1001/archopht.1975.01010020575004.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.