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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00548197
Other study ID # 85-A-57
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2007
Est. completion date March 2008

Study information

Verified date February 2007
Source Iran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used.

Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery..

In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation.

During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.


Description:

Eligibility criteria:

Diabetic tractional retinal detachment-complexity score between 4 and 8

Main outcome measures:

best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy.

- Complexity score between 4 and 8.

Exclusion Criteria:

- Previous vitreoretinal surgery.

- Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.

Study Design


Intervention

Drug:
Bevacizumab
one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy

Locations

Country Name City State
Iran, Islamic Republic of Rasool Akram Hospital Tehran

Sponsors (1)

Lead Sponsor Collaborator
Iran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (3)

Castellarin A, Grigorian R, Bhagat N, Del Priore L, Zarbin MA. Vitrectomy with silicone oil infusion in severe diabetic retinopathy. Br J Ophthalmol. 2003 Mar;87(3):318-21. — View Citation

Grisanti S, Biester S, Peters S, Tatar O, Ziemssen F, Bartz-Schmidt KU; Tuebingen Bevacizumab Study Group. Intracameral bevacizumab for iris rubeosis. Am J Ophthalmol. 2006 Jul;142(1):158-60. — 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Best Corrected Visual Acuity Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses) last follow up, an average of 7 months post-operation
Secondary Anatomic Status of the Retina Number of Participants with Postoperative Vitreous Hemorrhage Last follow up, an average of 7 months post-operation
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