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Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation

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ClinicalTrials.gov Identifier: NCT00673296
Recruitment Status : Unknown
Verified April 2008 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2008
Last Update Posted : May 7, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

Diabetic premacular hemorrhage occurs when blood from preretinal neovascular tissue is entrapped between the retina and the posterior hyaloid in the macular area. It may occur spontaneously or secondary to traction from a localized posterior vitreous detachment. This complication may greatly disturb the central vision and may be an important stimulant of fibrovascular proliferation.

Bevacizumab (Avastin, Genentech, Inc.) is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), which has been used to treat a variety of neovascular ocular diseases. In proliferative diabetic retinopathy, intravitreal bevacizumab has been shown to induce prompt regression of neovascularization and may enhance resolution of vitreous hemorrhage.

In this study, we propose that simultaneous intravitreal injection of gas and bevacizumab may be a useful treatment option in diabetic premacular hemorrhage with active fibrovascular tissue. In this procedure, gas is used to displace the blood while bevacizumab may render the neovascularization less active to decrease the likelihood of recurrent hemorrhage.


Condition or disease Intervention/treatment
Diabetic Retinopathy With Premacular Hemorrhage Drug: Intravitreal Bevacizumab

Detailed Description:
In this study, consecutive cases of acute diabetic premacular hemorrhage and active fibrovascular proliferation will receive intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL) during the same setting. Before intravitreal injection, all patients should either have complete panretinal photocoagulation (PRP) treatment or PRP to the peripheral retina. After treatment, patients will maintain a prone position for three days and be followed at regular interval. After vitreous clear-up, further supplementary PRP extending beyond equator will be done. Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination will be performed before treatment and at each follow-up visit. Data including the extent of premacular hemorrhage, and the interval between the treatment and clearing of premacular hemorrhage will also be recorded.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation
Study Start Date : January 2007
Primary Completion Date : April 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
A
Patients receive intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)
Drug: Intravitreal Bevacizumab
Intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)


Outcome Measures

Primary Outcome Measures :
  1. Interval between the treatment and clearing of premacular hemorrhage [ Time Frame: Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption ]

Secondary Outcome Measures :
  1. Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination. [ Time Frame: Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute diabetic premacular hemorrhage and minor active fibrovascular proliferation

Exclusion Criteria:

  • Anticoagulant therapy
  • Blood diseases associated with abnormal coagulation
  • Proliferative retinopathy severe enough to warrant vitrectomy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673296


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chung May Yang, M.D. National Taiwan University Hospital
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chung-May Yang, M.D., Natinal Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00673296     History of Changes
Other Study ID Numbers: 200711050R
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: April 2008

Keywords provided by National Taiwan University Hospital:
Bevacizumab
Diabetic premacular hemorrhage
Intravitreal gas

Additional relevant MeSH terms:
Hemorrhage
Diabetic Retinopathy
Pathologic Processes
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents