Diabetes ComplicationsNCT01422018
Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
A study testing Avastin (bevacizumab) in people with Diabetes Complications, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy. Design: Prospective interventional case series. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- Avastin (bevacizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Feb 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of either gender aged > 18 years
- patients with type 2 diabetes
- central macular thickness > 300 µm on OCT
- eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (< 500 µm)
- an area of retinal thickening less than 2 disc areas in diameter
- 67% or more of leakage associated with microaneurysms
Who cannot join
- eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye
- eyes with any pharmacologic intervention on fellow eye within 6 months
- history of ocular diseases other than diabetic retinopathy
- surgical history other than cataract extraction with intraocular lens implantation
- panretinal photocoagulation within 3 months of enrollment
- media opacity
- any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St Mary's hospital
Seocho, Seoul, 137-070
Sohee Jeon, MD, 82-10-7176-1357, soheeeee@gmail.com
About this study
Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy.
Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).
- Conditions
- Diabetes Complications
- Being tested
- Avastin (bevacizumab)
- Keywords
- clinically significant macular edema, diabetic macular edema, focal edema, focal laser photocoagulation, hard exudates, intravitreal bevacizumab
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin (bevacizumab)Drug
Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)
| Study group | Role | What they receive |
|---|---|---|
| one arm for Anastin injection | Experimental | intravitreal Avastin injection Receives: Drug: Avastin (bevacizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in best-corrected visual acuity (BCVA)
ETDRS BCVA will be measured after 6 6 serial IVB.
Measured: from month 0 to month 6 in monthly schedule (upto 6 months)
Secondary outcomes (2)
amount of hard exudates detected on fundus photography
on fundus photography
Measured: from month 0 to month 6 in bimonthly schedule (upto 6 months)
macular edema detected by optical coherent tomography
central subfield thickness will be measured.
Measured: from month 0 to month 6 in bimonthly schedule (upto 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ki Lee, Seoul St. Mary's Hospital
- Investigators
- Won ki Lee, MD Ph.D, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422018
- Sponsor's protocol ID
- KC11MISI0439
- Status last verified
- Sep 2011
- First submitted
- 5 Aug 2011
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01422018
- Acronym / sponsor ID
- KC11MISI0439
- Conditions
- Diabetes Complications
- Keywords
- clinically significant macular edema, diabetic macular edema, focal edema, focal laser photocoagulation, hard exudates, intravitreal bevacizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 23 Aug 2011 (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.
Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy.
Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm for Anastin injection | Experimental | Drug: Avastin (bevacizumab)intravitreal Avastin injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients of either gender aged > 18 years
- patients with type 2 diabetes
- central macular thickness > 300 µm on OCT
- eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (< 500 µm)
- an area of retinal thickening less than 2 disc areas in diameter
Key exclusion criteria (7 listed)
- eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye
- eyes with any pharmacologic intervention on fellow eye within 6 months
- history of ocular diseases other than diabetic retinopathy
- surgical history other than cataract extraction with intraocular lens implantation
- panretinal photocoagulation within 3 months of enrollment
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 |
|---|---|---|
| Avastin (bevacizumab)Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA) | Drug | one arm for Anastin injection |
Primary outcome
Changes in best-corrected visual acuity (BCVA)
Time frame: from month 0 to month 6 in monthly schedule (upto 6 months)
ETDRS BCVA will be measured after 6 6 serial IVB.
2 secondary outcomes
amount of hard exudates detected on fundus photography
Time frame: from month 0 to month 6 in bimonthly schedule (upto 6 months)
macular edema detected by optical coherent tomography
Time frame: from month 0 to month 6 in bimonthly schedule (upto 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
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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.
Won ki Lee, MD Ph.D principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avastin (bevacizumab) in people with Diabetes Complications, run by Seoul St. Mary's Hospital 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Sep 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohee Jeon, MD (82-10-7176-1357, soheeeee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in best-corrected visual acuity (BCVA) (time frame: from month 0 to month 6 in monthly schedule (upto 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2011.