Clinical trial NCT00423059: Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Official title: Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: intravitreal bevacizumab
proliferative diabetic retinopathy
VEGF
PEDF
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, intravitreal bevacizumab (Avastin) injection has gained popularity as a potential treatment of intraocular neovascularization (CNV) associated with age related macular degeneration and diabetic retinopathy. The efficacy of the drug is thought to be related with its pharmacologic blockade of VEGF.

The purpose of this study is to determine the effect of the intravitreal bevacizumab on the fibrovascular membrane associated with proliferative diabetic retinopathy by objective histologic evaluation.

The patients scheduled for vitrectomy for tractional fibrovascular membrane due to proliferative diabetic retinopathy will be randomized into two treatment groups. The one will receive conventional vitrectomy and the other group will receive intravitreal bevacizumab injection one week before the scheduled vitrectomy. The fibrovascular membrane will be excised during surgery and fixated for histologic examinations. The expression of VEGF and PEDF, a potent inhibitor of angiogenesis, will be evaluated in the fibrovascular membrane by immunohistochemistry. The results will be compared between two treatment groups.


Eligibility criteria: Inclusion Criteria:

* Tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy
* Severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation

Exclusion Criteria:

* Uncontrolled systemic hypertension
* Recent history of myocardiac infarction within 6 months
* Recent history of cerebrovascular accident within 6 months

Primary outcomes:
measure: expression level of VEFG
measure: PEDG
measure: Factor VIII
Secondary outcomes:
measure: complication rate
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
affiliation: Department of Ophthalmology, Yonsei University College of Medicine
name: Hyoung Jun Koh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available.
citation: Mason JO 3rd, Nixon PA, White MF. Intravitreal injection of bevacizumab (Avastin) as adjunctive treatment of proliferative diabetic retinopathy. Am J Ophthalmol. 2006 Oct;142(4):685-8. doi: 10.1016/j.ajo.2006.04.058.
citation: Matsuoka M, Ogata N, Minamino K, Matsumura M. Expression of pigment epithelium-derived factor and vascular endothelial growth factor in fibrovascular membranes from patients with proliferative diabetic retinopathy. Jpn J Ophthalmol. 2006 Mar-Apr;50(2):116-20. doi: 10.1007/s10384-005-0294-9.
citation: Avery RL, Pearlman J, Pieramici DJ, Rabena MD, Castellarin AA, Nasir MA, Giust MJ, Wendel R, Patel A. Intravitreal bevacizumab (Avastin) in the treatment of proliferative diabetic retinopathy. Ophthalmology. 2006 Oct;113(10):1695.e1-15. doi: 10.1016/j.ophtha.2006.05.064.
citation: Oshima Y, Sakaguchi H, Gomi F, Tano Y. Regression of iris neovascularization after intravitreal injection of bevacizumab in patients with proliferative diabetic retinopathy. Am J Ophthalmol. 2006 Jul;142(1):155-8. doi: 10.1016/j.ajo.2006.02.015.
citation: Bakri SJ, Donaldson MJ, Link TP. Rapid regression of disc neovascularization in a patient with proliferative diabetic retinopathy following adjunctive intravitreal bevacizumab. Eye (Lond). 2006 Dec;20(12):1474-5. doi: 10.1038/sj.eye.6702364. Epub 2006 May 5. No abstract available.
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.