Diabetic Macula EdemaPhase 4END-DMENCT02462304
To Compare Anti-VEGF Monotherapy With Anti-VEGF and EPM Grid Laser Combination Therapy for Diabetic Macular Edema
A Phase 4 study testing End-Point-Management grid laser, ranibizumab and Bevacizumab in people with Diabetic Macula Edema, run by The University of Hong Kong at 1 site in China.
Trial summary
Objectives: To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth Factor and end-point-management grid laser photocoagulation for diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macula Edema
- What is being tested?
- End-Point-Management grid laser, ranibizumab and Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years with CSME
- Diagnosis of diabetes mellitus (type 1 or type 2)
- At least one eye meets the study eye criteria
- Able and willing to provide informed consent prior to any study-related procedures
- Central foveal thickness ≥ 300 microns at baseline (SPECTRALIS or Cirrus HD OCT)
- LogMAR Best corrected visual acuity 0.20 (Snellen 20/30) to 1.3 (Snellen 20/400).
Show all 9Show fewer
- Willing and able to comply with clinic visits and study-related procedures
- Central Foveal Thickness on OCT 300-600 micron
- After first injection, wait for ME to reduce before proceeding with the laser. Exclude if ME persists >500um at the 4-week follow up
Who cannot join
- Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, VMT, pigment epithelium abnormalities, dense subfoveal hard exudates, non-retinal condition such as glaucoma etc).
- Substantial cataract that, in the opinion of the investigator, is likely to be affecting visual acuity. Likely to be affecting BCVA and performing laser treatment.
- History of treatment for diabetic macular edema at any time in the past (such as grid macular photocoagulation).
- History of treatment for diabetic macular edema at any time in the past 3 months (such as intravitreal or peribulbar corticosteroids, ranibizumab, bevacizumab, aflibercept).
- Focal laser photocoagulation should be performed before enrolling into the study if needed. 3 months gap required between last laser procedure and recruitment.
Show all 26Show fewer
- History of panretinal (scatter) photocoagulation (PRP) within 3 months prior to enrollment.
- Anticipated need for PRP in the study period.
- History of major retinal surgery (including vitrectomy, scleral buckle, any glaucoma surgery, etc.).
- History of YAG capsulotomy performed within 3 months.
- Aphakia.
- Intraocular pressure ≥ 25 mmHg.
- History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion criterion).
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant Blepharitis.
- Systemic Exclusion Criteria: A subject is not eligible if any of the following exclusion criteria are present:
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
- Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
- Systemic anti-vascular growth factor (ranibizumab) or pro-VEGF treatment within 4 months.
- For women of childbearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the study.
- The target eye is the only eye of the subject, with the fellow eye's visual acuity lower than 1.3 LogMAR units.
- Baseline logMAR BCVA from 0.05 to 0.5 (Snellen)
- Fellow eye BCVA 0.05 or worse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Efficacy of Monotherapy With Anti-Vascular Endothelial Growth Factor (Ranibizumab or Bevacizumab) Versus Combination Therapy With Anti-Vascular Endothelial Growth Factor and End-point-management Grid Laser Photocoagulation for Diabetic Macular Edema
Objectives:
To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth Factor and end-point-management grid laser photocoagulation for diabetic macular edema.
Read more
Study design:
Open-label non-randomized interventional study.
Study overview:
This study aims to look at the efficacy of treating diabetic macular edema (DME) with either anti-Vascular Endothelial Growth Factor(anti-VEGF) monotherapy, compared with combination therapy with anti-VEGF and End-Point-Management (EPM) grid laser photocoagulation, over a period of 6 months.
Various sites from across Asia (Japan, South Korea, Hong Kong) will participate. Depending on the availability of EPM laser, sites can either contribute to the 'Anti-VEGF monotherapy' arm, or to the 'Combination therapy' arm.
- Conditions
- Diabetic Macula Edema
- Being tested
- End-Point-Management grid laser, ranibizumab, Bevacizumab
- Keywords
- Diabetic Macula Edema, End-Point-Management, ranibizumab, bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-Point-Management grid laserProcedure or surgery
ranibizumabDrug
BevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Combination Anti-VEGF and EPM laser | Experimental | Subjects will receive both anti-VEGF injections and EPM laser. Receives: Procedure: End-Point-Management grid laser; Drug: ranibizumab; Drug: Bevacizumab |
| Anti-VEGF monotherapy | Active comparator | Subjects will receive anti-VEGF injections monotherapy. Receives: Drug: ranibizumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in number of anti-VEGF required
The number of injections of anti-VEGF required at the end of the 6 months period.
Measured: 6 months
Secondary outcomes (6)
Change in best corrected visual acuity
The change in best corrected visual acuity among subjects in different groups at the end of the 6 months period when compared to baseline.
Measured: 6 months
Central retinal thickness
The change in central retinal thickness among subjects in different groups at the end of the 6 months period when compared to baseline.
Measured: 6 months
Treatment related complications
This will look at treatment related complications in terms of changes in intraocular pressure post-injection
Measured: 6 months
Treatment related complications
This will look at treatment related complications in terms of infection
Measured: 6 months
Treatment related complications
This will look at treatment related complications in terms of retinal detachment
Measured: 6 months
Recurrence of macular edema
Recurrence of macular edema during the 6 months period will be monitored.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macula EdemaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Nagoya City University, Asahikawa Medical College, University of Fukui, Eguchi Eye Clinic, Kyoto University, Nagasaki University, Osaka Medical College, Kyushu University, Tokyo Medical University Hachioji Medical Centre, Hokkaido University, Kyorin University, Inje University, Pusan National University, Kyungpook National University Hospital, Chungnam National University Hospital, Sun Cheon Hyang University, Kyunghee University, Yeungnam University Hospital, Korea University, National University Hospital, Singapore, Yamagata University
- Responsible party
- Principal investigator, Dr. WONG Yat-hin Ian, The University of Hong Kong
- Investigators
- Ian Wong, FRCOphth, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462304
- Sponsor's protocol ID
- END-DME1
- Acronym
- END-DME
- Status last verified
- Apr 2016
- First submitted
- 23 Mar 2015
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Efficacy of Monotherapy With Anti-Vascular Endothelial Growth Factor (Ranibizumab or Bevacizumab) Versus Combination Therapy With Anti-Vascular Endothelial Growth Factor and End-point-management Grid Laser Photocoagulation for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02462304
- Acronym / sponsor ID
- END-DME / END-DME1
- Conditions
- Diabetic Macula Edema
- Keywords
- Diabetic Macula Edema, End-Point-Management, ranibizumab, bevacizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Nagoya City University, Asahikawa Medical College, University of Fukui, Eguchi Eye Clinic, Kyoto University, Nagasaki University, Osaka Medical College, Kyushu University, Tokyo Medical University Hachioji Medical Centre, Hokkaido University, Kyorin University, Inje University, Pusan National University, Kyungpook National University Hospital, Chungnam National University Hospital, Sun Cheon Hyang University, Kyunghee University, Yeungnam University Hospital, Korea University, National University Hospital, Singapore, Yamagata University
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Jun 2015 (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.
Objectives:
To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth Factor and end-point-management grid laser photocoagulation for diabetic macular edema.
Study design:
Open-label non-randomized interventional study.
Study overview:
This study aims to look at the efficacy of treating diabetic macular edema (DME) with either anti-Vascular Endothelial Growth Factor(anti-VEGF) monotherapy, compared with combination therapy with anti-VEGF and End-Point-Management (EPM) grid laser photocoagulation, over a period of 6 months.
Various sites from across Asia (Japan, South Korea, Hong Kong) will participate. Depending on the availability of EPM laser, sites can either contribute to the 'Anti-VEGF monotherapy' arm, or to the 'Combination therapy' arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Anti-VEGF and EPM laser | Experimental | Procedure: End-Point-Management grid laser, Drug: ranibizumab, Drug: BevacizumabSubjects will receive both anti-VEGF injections and EPM laser. |
| Anti-VEGF monotherapy | Active comparator | Drug: ranibizumab, Drug: BevacizumabSubjects will receive anti-VEGF injections monotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years with CSME
- Diagnosis of diabetes mellitus (type 1 or type 2)
- At least one eye meets the study eye criteria
- Able and willing to provide informed consent prior to any study-related procedures
- Central foveal thickness ≥ 300 microns at baseline (SPECTRALIS or Cirrus HD OCT)
Key exclusion criteria (26 listed)
- Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, VMT, pigment epithelium abnormalities, dense subfoveal hard exudates, non-retinal condition such as glaucoma etc).
- Substantial cataract that, in the opinion of the investigator, is likely to be affecting visual acuity. Likely to be affecting BCVA and performing laser treatment.
- History of treatment for diabetic macular edema at any time in the past (such as grid macular photocoagulation).
- History of treatment for diabetic macular edema at any time in the past 3 months (such as intravitreal or peribulbar corticosteroids, ranibizumab, bevacizumab, aflibercept).
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 |
|---|---|---|
| End-Point-Management grid laser | Procedure or surgery | Combination Anti-VEGF and EPM laser |
| ranibizumab | Drug | Anti-VEGF monotherapy, Combination Anti-VEGF and EPM laser |
| Bevacizumab | Drug | Anti-VEGF monotherapy, Combination Anti-VEGF and EPM laser |
Primary outcome
Difference in number of anti-VEGF required
Time frame: 6 months
The number of injections of anti-VEGF required at the end of the 6 months period.
6 secondary outcomes
Change in best corrected visual acuity
Time frame: 6 months
Central retinal thickness
Time frame: 6 months
Treatment related complications
Time frame: 6 months
Treatment related complications
Time frame: 6 months
Treatment related complications
Time frame: 6 months
Recurrence of macular edema
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
Related trials for Diabetic Macula Edema
Recruiting
Acute Intra Ocular Pressure Monitoring After Aflibercept 8mg/0.07mL
Macular Diseases
Active, not recruitingObservational study
The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema
Visual Impairment, Neovascular Age-related Macular Degeneration (nAMD)
Not yet recruiting
Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates
Diabetic Macular Edema, Neovascular (Wet) Age-Related Macular Degeneration
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.
Ian Wong, FRCOphth principal investigator
The University of Hong Kong
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 End-Point-Management grid laser, ranibizumab and Bevacizumab in people with Diabetic Macula Edema, run by The University of Hong Kong at 1 site in China.
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 9 inclusion and 26 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 19 Apr 2016. 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 China. 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?
Results are not available in the source record.
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?
Difference in number of anti-VEGF required (time frame: 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 19 Apr 2016.