Visual Impairment Due to Diabetic Macular Edema
Conditions
Keywords
Diabetic macular edema, DME, Proliferative diabetic retinopathy, PDR, ranibizumab, laser
Brief summary
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
Interventions
PROCEDUREActive laser photocoagulation
Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
DRUGSham injections
Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Sponsors
Novartis Pharmaceuticals
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
* Visual acuity impairment caused by macular edema in at least one eye * Type 1 or type 2 diabetes mellitus * Stable medication of diabetes in past 3 month
Exclusion criteria
* Patients with uncontrolled systemic or ocular diseases * Laser photocoagulation in the study eye for the last 3 months * Any history of any intraocular surgery in the study eye within the past 3 months * Blood pressure \> 160/100 mmHg Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | 12 months | Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA. |
Countries
Germany
Participant flow
Recruitment details
Participants did not complete study due to early termination. Study was terminated because of drug approval.
Participants by arm
| Arm | Count |
|---|---|
| Active Laser Photocoagulation and Ranibizumab Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. | 85 |
| Active Laser Photocoagulation and Sham Injection Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. | 43 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal laboratory value | 1 | 0 |
| Overall Study | Administrative problems | 1 | 1 |
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Study termination | 78 | 32 |
| Overall Study | Unsatisfactory therapeutic effect | 0 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Active Laser Photocoagulation and Ranibizumab | Active Laser Photocoagulation and Sham Injection | Total |
|---|---|---|---|
| Age Continuous >=18 years | 63.5 years STANDARD_DEVIATION 9.3 | 63.5 years STANDARD_DEVIATION 10.5 | 63.5 years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 32 Participants | 16 Participants | 48 Participants |
| Sex: Female, Male Male | 53 Participants | 27 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 85 | 10 / 43 |
| serious Total, serious adverse events | 14 / 85 | 5 / 43 |
Outcome results
Primary
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.
Time frame: 12 months
Population: Full Analysis Set consisted of all participants who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. No patient completed the 12 months observational period due to study early termination; therefore, the last observation carried forward (LOCF) method was used with data from 11.1 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Laser Photocoagulation and Ranibizumab | Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | 6.5 Letters | Standard Deviation 8.6 |
| Active Laser Photocoagulation and Sham Injection | Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | 1.4 Letters | Standard Deviation 7.3 |