Intravitreal Bevacizumab vs Photocoagulation for Proliferative Diabetic Retinopathy

NCT00347698 | Withdrawn Phase 2

• 1 other identifier: APEC-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy; bevacizumab; photocoagulation

Outcome Measures

Primary Outcomes (4)

• Best corrected visual acuity at six months and one year

• Macular thickness measured by OCT at six months and one year

• Median deviation in visual fields at one year

• Score on a patient satisfaction scale at six months and one year

Secondary Outcomes (1)

• Complications associated to each treatment

Interventions

intravitreal injection of bevacizumab DRUG

panretinal photocoagulation PROCEDURE

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Asociación para Evitar la Ceguera en México

Mexico City, D. F, 04030, Mexico

Location

Related Publications (10)

• 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.

  PMID: 3658348 BACKGROUND

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

  PMID: 1171677 BACKGROUND

• 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.

  PMID: 16458724 BACKGROUND

• 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.

  PMID: 12597922 BACKGROUND

• 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.

  PMID: 9377574 BACKGROUND

• 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.

  PMID: 16508426 BACKGROUND

• 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.

  PMID: 16508438 BACKGROUND

• 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.

  PMID: 16508427 BACKGROUND

• 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.

  PMID: 16156152 BACKGROUND

• 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.

  PMID: 16156153 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Gerardo García-Aguirre, MD

  Asociación para Evitar la Ceguera en México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: March 1, 2006
• Primary Completion: March 1, 2006
• Study Completion: August 1, 2007
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

ME (1)