Diabetic RetinopathyNCT00423059
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
A study testing bevacizumab in people with Diabetic Retinopathy, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- bevacizumab
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy
- Severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation
Who cannot join
- Uncontrolled systemic hypertension
- Recent history of myocardiac infarction within 6 months
- Recent history of cerebrovascular accident within 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Yonsei University College of Medicine
Seoul, 120-752
About this study
Official title: Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)
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.
- Conditions
- Diabetic Retinopathy
- Being tested
- bevacizumab
- Keywords
- intravitreal bevacizumab, proliferative diabetic retinopathy, VEGF, PEDF
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
expression level of VEFG
PEDG
Factor VIII
Secondary outcomes (1)
complication rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startDec 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Hyoung Jun Koh, Principal investigator, Department of Ophthalmology, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423059
- Sponsor's protocol ID
- koh01
- Status last verified
- Jan 2007
- First submitted
- 16 Jan 2007
- Last updated
- 13 Mar 2007
- Results posted
- No
Publications
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.
PubMed 16829817Mason 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.
PubMed 17011869Matsuoka 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.
PubMed 16604386Avery 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.
PubMed 17011951Oshima 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.
PubMed 16815267Bakri 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.
PubMed 16680105Spaide 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.
PubMed 16508426
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic Changes of Fibrovascular Membrane Associated With Proliferative Diabetic Retinopathy After Intravitreal Bevacizumab (Avastin®)
- ClinicalTrials.gov ID
- NCT00423059
- Acronym / sponsor ID
- koh01
- Conditions
- Diabetic Retinopathy
- Keywords
- intravitreal bevacizumab, proliferative diabetic retinopathy, VEGF, PEDF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Mar 2007
- First posted
- 17 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy
- Severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation
Key exclusion criteria (3 listed)
- Uncontrolled systemic hypertension
- Recent history of myocardiac infarction within 6 months
- Recent history of cerebrovascular accident within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab | Drug | – |
Primary outcome
expression level of VEFG
PEDG
Factor VIII
1 secondary outcome
complication rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2007.
- Background: PubMed 16829817Chen 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.
- Background: PubMed 17011869Mason 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.
- Background: PubMed 16604386Matsuoka 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.
- Background: PubMed 17011951Avery 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.
- Background: PubMed 16815267Oshima 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.
- Background: PubMed 16680105Bakri 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.
- Background: PubMed 16508426Spaide 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoung Jun Koh principal investigator
Department of Ophthalmology, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bevacizumab in people with Diabetic Retinopathy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression level of VEFG. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00423059, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2007.