Intravitreal Bevacizumab vs Photocoagulation for Proliferative Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Intravitreal Bevacizumab vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-year Prospective, Contralateral Eye Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00347698
• Other study ID #: APEC-007
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: March 2006
• Est. completion date: August 2007

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2007
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• intravitreal injection of bevacizumab

Procedure:
• panretinal photocoagulation

Locations

Country	Name	City	State
Mexico	Asociación para Evitar la Ceguera en México	Mexico City	D. F

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

References & Publications (10)

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. — View Citation

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

Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, Krummen L, Winkler M, Ferrara N. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res. 1997 Oct 15;57(20):4593-9. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Witmer AN, Vrensen GF, Van Noorden CJ, Schlingemann RO. Vascular endothelial growth factors and angiogenesis in eye disease. Prog Retin Eye Res. 2003 Jan;22(1):1-29. doi: 10.1016/s1350-9462(02)00043-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity at six months and one year
Primary	Macular thickness measured by OCT at six months and one year
Primary	Median deviation in visual fields at one year
Primary	Score on a patient satisfaction scale at six months and one year
Secondary	Complications associated to each treatment