Macular Edema
Conditions
Brief summary
This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).
Interventions
DRUGDexamethasone
Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10.
PROCEDURELaser Photocoagulation
Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Sponsors
Tigermed Consulting Co., Ltd
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of diabetes mellitus (type 1 or type 2) * Presence of macular edema
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye | 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. |
| Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye | Baseline to Month 12 | 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. |
| Change From Baseline in Total Macular Leakage Area by FA in the Study Eye | Baseline to Month 12 | 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. |
Countries
China, Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Photocoagulation Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated. | 127 |
| Dexamethasone Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10. | 145 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 3 |
| Overall Study | Consent Withdrawn | 1 | 0 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Participant Dropped-out | 0 | 1 |
| Overall Study | Participant was Deemed Unsuitable | 1 | 0 |
| Overall Study | Personal Reasons | 19 | 5 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Dexamethasone | Laser Photocoagulation | Total |
|---|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 8.08 | 59.5 years STANDARD_DEVIATION 7.73 | 59.3 years STANDARD_DEVIATION 7.91 |
| BCVA in the Study Eye | 55.7 letters STANDARD_DEVIATION 11.44 | 55.1 letters STANDARD_DEVIATION 10.32 | 55.4 letters STANDARD_DEVIATION 10.91 |
| Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) in the Study Eye | 491.2 microns STANDARD_DEVIATION 160.8 | 482.1 microns STANDARD_DEVIATION 154.39 | 486.9 microns STANDARD_DEVIATION 157.61 |
| Race/Ethnicity, Customized Ethnicity Chinese | 129 Participants | 113 Participants | 242 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 16 Participants | 14 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 145 Participants | 127 Participants | 272 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 64 Participants | 69 Participants | 133 Participants |
| Sex: Female, Male Male | 81 Participants | 58 Participants | 139 Participants |
| Total Macular Leakage Area by Fluorescein Angiography (FA) in the Study Eye | 29.644 mm^2 | 30.076 mm^2 | 29.8 mm^2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 129 | 2 / 145 |
| other Total, other adverse events | 51 / 129 | 99 / 145 |
| serious Total, serious adverse events | 21 / 129 | 35 / 145 |
Outcome results
Primary
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.
Time frame: Baseline to Month 12
Population: mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Laser Photocoagulation | Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye | 1.4 letters | Standard Error 0.65 |
| Dexamethasone | Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye | 4.3 letters | Standard Error 0.61 |
p-value: 0.001195% CI: [1.17, 4.66]ANCOVA
Secondary
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.
Time frame: Baseline to Month 12
Population: mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement. Last observation carried forward (LOCF) was used
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Laser Photocoagulation | Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye | -120.3 microns | Standard Error 13.2 |
| Dexamethasone | Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye | -209.5 microns | Standard Error 12.27 |
p-value: <0.000195% CI: [-122.53, -56.01]ANCOVA
Secondary
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.
Time frame: Baseline to Month 12
Population: mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement. LOCF was used. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Laser Photocoagulation | Change From Baseline in Total Macular Leakage Area by FA in the Study Eye | -0.637 mm^2 | Standard Error 0.8133 |
| Dexamethasone | Change From Baseline in Total Macular Leakage Area by FA in the Study Eye | -8.367 mm^2 | Standard Error 0.7482 |
p-value: <0.000195% CI: [-9.7855, -5.6733]ANCOVA
Secondary
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.
Time frame: Baseline to Month 12
Population: mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser Photocoagulation | Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye | 10.2 percentage of participants |
| Dexamethasone | Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye | 11.7 percentage of participants |
p-value: 0.743195% CI: [-5.9, 8.9]Cochran-Mantel-Haenszel