Vitreous HemorrhagePhase 4NCT01724385
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
A Phase 4 study testing intravitreal injection of bevacizumab in people with Vitreous Hemorrhage and Proliferative Diabetic Retinopathy, run by Khon Kaen University at 1 site in Thailand.
Trial summary
To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Vitreous Hemorrhage, Proliferative Diabetic Retinopathy
- What is being tested?
- intravitreal injection of bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2012to Dec 2012
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with diabetes mellitus
- proliferative diabetic retinopathy
- prior complete panretinal photocoagulation
- presented with new dense vitreous hemorrhage
Who cannot join
- one-eyed patient
- previous intraocular surgery
- severe lens opacity precluding fundus examination
- advance glaucoma
- history of thromboembolic events such as myocardial infarction and cerebrovascular accident
- uncontrolled systemic hypertension, systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
Show all 9Show fewer
- known coagulation abnormalities or current use of anticoagulant medications other than aspirin
- known allergies to any relevant drugs in this study
- evidence of external ocular infection such as conjunctivitis and significant blepharitis.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation
To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).
Read the detailed description
The investigators will carry out a prospective study in patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. Re-injection will be done in non-clearing and recurrent VH.
- Being tested
- intravitreal injection of bevacizumab
- Keywords
- bevacizumab,, proliferative diabetic retinopathy,, vitreous hemorrhage,
- Medical subject headings
- Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of bevacizumabDrug
Also called Avastin
intravitreal injection of bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| intravitreal bevacizumab injection | Experimental | intravitreal injection of bevacizumab 1.25 mg Receives: Drug: intravitreal injection of bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of eyes that vitreous hemorrhage has been completely resolved
The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.
Measured: 12 months
Secondary outcomes (1)
The change in best corrected visual acuity (BCVA) from baseline
The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreous HemorrhageStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosanan Yospaiboon, Khon Kaen University
- Investigators
- Suthasinee Sinawat, M.D., Principal investigator, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724385
- Sponsor's protocol ID
- I55116
- Status last verified
- Apr 2013
- First submitted
- 7 Nov 2012
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation
- ClinicalTrials.gov ID
- NCT01724385
- Acronym / sponsor ID
- I55116
- Keywords
- bevacizumab,, proliferative diabetic retinopathy,, vitreous hemorrhage,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Nov 2012 (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.
To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).
Detailed description
The investigators will carry out a prospective study in patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. Re-injection will be done in non-clearing and recurrent VH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravitreal bevacizumab injection | Experimental | Drug: intravitreal injection of bevacizumabintravitreal injection of bevacizumab 1.25 mg |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with diabetes mellitus
- proliferative diabetic retinopathy
- prior complete panretinal photocoagulation
- presented with new dense vitreous hemorrhage
Key exclusion criteria (9 listed)
- one-eyed patient
- previous intraocular surgery
- severe lens opacity precluding fundus examination
- advance glaucoma
- history of thromboembolic events such as myocardial infarction and cerebrovascular accident
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 |
|---|---|---|
| intravitreal injection of bevacizumabAlso: Avastinintravitreal injection of bevacizumab | Drug | intravitreal bevacizumab injection |
Primary outcome
The percentage of eyes that vitreous hemorrhage has been completely resolved
Time frame: 12 months
The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.
1 secondary outcome
The change in best corrected visual acuity (BCVA) from baseline
Time frame: 12 months
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 26 Apr 2013.
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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.
Suthasinee Sinawat, M.D. principal investigator
Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravitreal injection of bevacizumab in people with Vitreous Hemorrhage and Proliferative Diabetic Retinopathy, run by Khon Kaen University at 1 site in Thailand.
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 4 inclusion and 9 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 26 Apr 2013. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The percentage of eyes that vitreous hemorrhage has been completely resolved (time frame: 12 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 26 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.