Macular EdemaPhase 3NCT02121262
A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema
A Phase 3 study testing Dexamethasone and Laser Photocoagulation in people with Macular Edema, run by Allergan at 18 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Dexamethasone and Laser Photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 8 Jan 2016to 1 Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Presence of macular edema
Who cannot join
- Anticipated need for ocular surgery in the study eye during the study
- Laser photocoagulation in the study eye within 3 months
- Cataract surgery within 3 months
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
China16 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
Beijing Friendship Hospital of Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Hospital
Beijing, Beijing Municipality, 100730
Beijing TongRen Hospital
Beijing, Beijing Municipality, 100730
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
The 2nd hospital of JiLin University
Changchun, Jilin, 130041
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Zhongshan Ophthalmic Center, Sun Yet-Sen University
Guangzhou, Guangdong, 510060
The First Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
The Eye and ENT Hospital, Affiliated of Fudan University
Shanghai, Shanghai Municipality, 200031
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020
TianJin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384
Wenzhou Ophthalmic Centre
Wenzhou, Zhejiang, 325027
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Philippines2 sites
Asian Eye Institute
Makati City, National Capital Region, 1200
Peregrine Eye and Laser Institute
Makati City, National Capital Region, 1209
About this study
Official title: Dexamethasone Posterior Segment Drug Delivery System Versus Laser Photocoagulation in Patients With Diabetic Macular Edema
This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).
- Conditions
- Macular Edema
- Being tested
- Dexamethasone, Laser Photocoagulation
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called OZURDEX®
Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10.
Laser PhotocoagulationProcedure or surgery
Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
| Study group | Role | What they receive |
|---|---|---|
| Laser Photocoagulation | Other | Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated. Receives: Procedure: Laser Photocoagulation |
| Dexamethasone | Experimental | Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. The average change was computed by subtracting the baseline BCVA from the area under the BCVA curve (AUC) divided by the total follow-up time for each participant. Analysis of covariance (ANCOVA) model was used for the analysis.
Measured: Baseline to Month 12
Secondary outcomes (3)
Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye.
Measured: Baseline to Month 12
Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye
CRT was assessed using SD-OCT, a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis.
Measured: Baseline to Month 12
Change From Baseline in Total Macular Leakage Area by FA in the Study Eye
FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Early and transit images were taken of the study eye. Mid- and late-phase images were taken of the study and non-study eye. Electronic FA images were collected for evaluation by a reading center. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study start8 Jan 2016
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular EdemaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Joanne Li, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121262
- Sponsor's protocol ID
- 206207-026
- Status last verified
- Oct 2020
- First submitted
- 22 Apr 2014
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Posterior Segment Drug Delivery System Versus Laser Photocoagulation in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02121262
- Acronym / sponsor ID
- 206207-026
- Conditions
- Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 17 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Photocoagulation | Other | Procedure: Laser PhotocoagulationLaser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated. |
| Dexamethasone | Experimental | Drug: DexamethasoneDexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Presence of macular edema
Key exclusion criteria (3 listed)
- Anticipated need for ocular surgery in the study eye during the study
- Laser photocoagulation in the study eye within 3 months
- Cataract surgery within 3 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 |
|---|---|---|
| DexamethasoneAlso: OZURDEX®Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10. | Drug | Dexamethasone |
| Laser PhotocoagulationLaser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated. | Procedure or surgery | Laser Photocoagulation |
Primary outcome
Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline to Month 12
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. The average change was computed by subtracting the baseline BCVA from the area under the BCVA curve (AUC) divided by the total follow-up time for each participant. Analysis of covariance (ANCOVA) model was used for the analysis.
3 secondary outcomes
Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye
Time frame: Baseline to Month 12
Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye
Time frame: Baseline to Month 12
Change From Baseline in Total Macular Leakage Area by FA in the Study Eye
Time frame: Baseline to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joanne Li study director
Allergan
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Laser Photocoagulation in people with Macular Edema, run by Allergan at 18 sites in 2 countries.
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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China, Philippines. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye (time frame: Baseline to Month 12). 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 17 Nov 2020.