Diabetic Macular Edema
Conditions
Keywords
DME, Diabetic, macula, edema, ranibizumab, REVEAL
Brief summary
This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).
Interventions
DRUGRanibizumab
Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.
PROCEDURELaser photocoagulation
Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.
DRUGSham ranibizumab
Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.
PROCEDURESham laser photocoagulation
Sham laser treatment administered at day 1.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Type 1 or Type 2 diabetes mellitus according to American Diabetes Association (ADA) or World Health Organization (WHO) guidelines with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. * Patients with visual impairment due to focal or diffuse Diabetic Macular Edema in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment. * The study eye must fulfill the following criteria at Visit 1: * Best-Corrected Visual Acuity (BCVA) score between 78 and 39 letters, inclusively, using Early Treatment of Diabetic Retinopathy (ETDRS) chart-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160). * Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator. * Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.
Exclusion criteria
* Ocular concomitant conditions/ diseases: * Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment. * Active intraocular inflammation in either eye. * Any active infection in either eye. * History of uveitis in either eye. * Uncontrolled glaucoma in either eye. * Ocular treatments: * Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study. * Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry. * Systemic conditions or treatments: * History of stroke * Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine level \> 2.0 mg/dL. * Untreated diabetes mellitus * Blood pressure systolic \> 160 mmHg or diastolic \> 100 mmHg * Compliance/ Administrative: * Pregnant or nursing (lactating) women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) | 12 months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | Up to 12 months | Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement. |
| Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | Up to 12 months | Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement. |
| Percent of Participants With Visual Acuity Above 73 Letters at Month 12 | 12 months | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome. |
| Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline | 12 months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement. |
| Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12 | 12 months | Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement. |
| Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline | 12 months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement. |
| Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline | 12 months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening. |
| Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12 | 12 months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. |
| Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D) | 12 months | The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0). |
| Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline | 12 months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening. |
Countries
China, Hong Kong, Japan, Singapore, South Korea, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adjunctive Treatment Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser. | 132 |
| Monotherapy Treatment Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser. | 133 |
| Laser Control Active laser treatment plus sham intravitreal injections. | 131 |
| Total | 396 |
Baseline characteristics
| Characteristic | Adjunctive Treatment | Monotherapy Treatment | Laser Control | Total |
|---|---|---|---|---|
| Age Continuous | 61.2 years STANDARD_DEVIATION 10.52 | 60.7 years STANDARD_DEVIATION 9.37 | 61.5 years STANDARD_DEVIATION 9.68 | 61.1 years STANDARD_DEVIATION 9.85 |
| Sex: Female, Male Female | 65 Participants | 52 Participants | 56 Participants | 173 Participants |
| Sex: Female, Male Male | 67 Participants | 81 Participants | 75 Participants | 223 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 133 | 36 / 132 | 23 / 128 |
| serious Total, serious adverse events | 21 / 133 | 22 / 132 | 19 / 128 |
Outcome results
Primary
Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement.
Time frame: 12 months
Population: The Full Analysis Set (FAS) consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adjunctive Treatment | Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) | 5.7 Letters | Standard Deviation 7.2 |
| Monotherapy Treatment | Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) | 5.9 Letters | Standard Deviation 6.02 |
| Laser Control | Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) | 1.4 Letters | Standard Deviation 6.49 |
Secondary
Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.
Time frame: 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adjunctive Treatment | Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12 | 6.4 Letters | Standard Deviation 10.67 |
| Monotherapy Treatment | Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12 | 6.6 Letters | Standard Deviation 7.68 |
| Laser Control | Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12 | 1.8 Letters | Standard Deviation 8.27 |
Secondary
Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12
Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement.
Time frame: 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had Central Retinal Subfield Thickness value with signal strength ≥ 5 for Carl Zeiss Optical Coherence Tomography 3 system.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adjunctive Treatment | Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12 | -171.8 micrometers | Standard Deviation 160.85 |
| Monotherapy Treatment | Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12 | -134.6 micrometers | Standard Deviation 131.17 |
| Laser Control | Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12 | -57.2 micrometers | Standard Deviation 118.6 |
Secondary
Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)
The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0).
Time frame: 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adjunctive Treatment | Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D) | 2.8 units on a scale | Standard Deviation 14.38 |
| Monotherapy Treatment | Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D) | -1.1 units on a scale | Standard Deviation 12.74 |
| Laser Control | Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D) | 1.0 units on a scale | Standard Deviation 13.9 |
Secondary
Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.
Time frame: 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Adjunctive Treatment | Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline | 37.2 Percentage of participants | 37.2 |
| Monotherapy Treatment | Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline | 33.8 Percentage of participants | 33.8 |
| Laser Control | Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline | 13.3 Percentage of participants | 13.3 |
Secondary
Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.
Time frame: 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adjunctive Treatment | Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline | 17.8 Percentage of participants |
| Monotherapy Treatment | Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline | 18.8 Percentage of participants |
| Laser Control | Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline | 7.8 Percentage of participants |
Secondary
Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening.
Time frame: 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adjunctive Treatment | Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline | 5.4 Percentage of participants |
| Monotherapy Treatment | Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline | 3.0 Percentage of participants |
| Laser Control | Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline | 6.3 Percentage of participants |
Secondary
Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening.
Time frame: 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adjunctive Treatment | Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline | 3.9 Percentage of participants |
| Monotherapy Treatment | Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline | 1.5 Percentage of participants |
| Laser Control | Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline | 3.9 Percentage of participants |
Secondary
Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline
Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement.
Time frame: Up to 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had intra-retinal cysts in any of the 6 sections of the study eye at baseline - not applicable means there was no intra-retinal cyst at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | complete resolution | 19.5 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | decrease | 40.3 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | no change | 5.2 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | increase | 1.3 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | not applicable | 2.6 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | missing | 31.2 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | missing | 28.2 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | complete resolution | 21.8 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | increase | 1.3 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | not applicable | 1.3 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | decrease | 42.3 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | no change | 5.1 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | decrease | 35.1 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | no change | 15.6 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | missing | 32.5 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | increase | 10.4 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | complete resolution | 6.5 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline | not applicable | 0 percentage of participants |
Secondary
Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline
Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement.
Time frame: Up to 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had sub-retinal fluid in any of the 6 sections of the study eye at baseline. Not applicable means there was no sub-retinal fluid at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | complete resolution | 13.6 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | decrease | 18.2 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | no change | 4.5 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | increase | 0 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | not applicable | 31.8 percentage of participants |
| Adjunctive Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | missing | 31.8 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | missing | 37.0 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | complete resolution | 33.3 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | increase | 0 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | not applicable | 18.5 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | decrease | 11.1 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | no change | 0 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | decrease | 18.8 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | no change | 6.3 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | missing | 37.5 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | increase | 0 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | complete resolution | 25.0 percentage of participants |
| Laser Control | Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline | not applicable | 12.5 percentage of participants |
Secondary
Percent of Participants With Visual Acuity Above 73 Letters at Month 12
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome.
Time frame: 12 months
Population: The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adjunctive Treatment | Percent of Participants With Visual Acuity Above 73 Letters at Month 12 | 20.5 percentage of participants |
| Monotherapy Treatment | Percent of Participants With Visual Acuity Above 73 Letters at Month 12 | 16.5 percentage of participants |
| Laser Control | Percent of Participants With Visual Acuity Above 73 Letters at Month 12 | 8.5 percentage of participants |