Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment

• Sponsor: Iran University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00548197
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 12.9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intravitreal Bevacizumab Injection; Pars Plana Vitrectomy; Tractional Retinal Detachment; Diabetic Retinopathy	Drug: Bevacizumab	Phase 1

Detailed 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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy	Drug: Bevacizumab; one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy; Other Names: Brand name of Bevacizumab is Avastin
No Intervention: Control group no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy

Outcome Measures

Primary Outcome Measures

1. Best Corrected Visual Acuity [last follow up, an average of 7 months post-operation]

   Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)

Secondary Outcome Measures

1. Anatomic Status of the Retina [Last follow up, an average of 7 months post-operation]

   Number of Participants with Postoperative Vitreous Hemorrhage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rasool Akram Hospital	Tehran		Iran, Islamic Republic of	14455-364

Sponsors and Collaborators

• Iran University of Medical Sciences

Investigators

• Study Director: Mehdi Modarres, MD, Iran University of Medical Sciences(IUMS)

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8.

• Responsible Party: Iran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT00548197
• Other Study ID Numbers: 85-A-57
• First Posted: Oct 23, 2007
• Last Update Posted: Oct 16, 2018
• Last Verified: Feb 1, 2007

• Keywords provided by Iran University of Medical Sciences: Intravitreal Bevacizumab injection; Pars plana vitrectomy; tractional retinal detachment; Diabetic retinopathy
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment; Dissociative Disorders; Bevacizumab

Study Results

Participant Flow

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy	Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Period Title: Overall Study
STARTED	18	22
COMPLETED	18	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy	no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy	Total of all reporting groups
Overall Participants	22	18	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.8 (11.3)	53.2 (11.7)	54.63 (11.48)
Sex: Female, Male (Count of Participants)
Female	12 54.5%	10 55.6%	22 55%
Male	10 45.5%	8 44.4%	18 45%

Outcome Measures

1. Primary Outcome

Title	Best Corrected Visual Acuity
Description	Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)
Time Frame	last follow up, an average of 7 months post-operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy	no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
Measure Participants	22	18
Mean (Standard Deviation) [LogMar]	1.1 (0.4)	1.4 (0.3)

2. Secondary Outcome

Title	Anatomic Status of the Retina
Description	Number of Participants with Postoperative Vitreous Hemorrhage
Time Frame	Last follow up, an average of 7 months post-operation

Outcome Measure Data

Analysis Population Description

Postoperative Vitreous Hemorrhage

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy	no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
Measure Participants	22	18
Count of Participants [Participants]	0 0%	7 38.9%

Adverse Events

Arm/Group Title	Intervention		Control
Arm/Group Description	Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy Bevacizumab: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy		no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/18 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/22 (4.5%)		1/18 (5.6%)
Eye disorders
Inferior rhegmatogenous retinal detachment and perisillicone proliferations	1/22 (4.5%)	1	1/18 (5.6%)	1
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.