Diabetic Macular Edema
Conditions
Keywords
Diabetes, Macular edema, Aliskiren, Diabetic retinopathy, Diabetes mellitus type 1, Diabetes mellitus type 2
Brief summary
To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema
Interventions
DRUGAliskiren
300 mg once daily
DRUGPlacebo
Matching placebo once daily
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes * Diabetic macular edema
Exclusion criteria
* Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months) * Recent laser photocoagulation in the study eye * Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment | Baseline to week 12 | The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor |
Countries
Denmark, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren 300 mg Aliskiren 300 mg once daily for 12 weeks | 20 |
| Placebo Matching placebo once daily for 12 weeks | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal laboratory value | 1 | 1 |
| Overall Study | Adverse Event | 3 | 2 |
Baseline characteristics
| Characteristic | Aliskiren 300 mg | Placebo | Total |
|---|---|---|---|
| Age Continuous | 64.3 years STANDARD_DEVIATION 10.76 | 60.1 years STANDARD_DEVIATION 10.57 | 62.2 years STANDARD_DEVIATION 10.74 |
| Age, Customized 18 - 64 years | 9 participants | 13 participants | 22 participants |
| Age, Customized 65 - 84 years | 11 participants | 6 participants | 17 participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 20 | 9 / 19 |
| serious Total, serious adverse events | 2 / 20 | 2 / 19 |
Outcome results
Primary
Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment
The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor
Time frame: Baseline to week 12
Population: This study was terminated early due to low recruitment of patients.