Visual Impairment Due to Diabetic Macular Edema
Conditions
Brief summary
The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in DME patients in a detailed time course.
Interventions
DRUGRanibizumab
0.5 mg intravitreal injections
DRUGAflibercept
2 mg intravitreal injections
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or Type 2 diabetes mellitus * Visual impairment predominantly due to DME.
Exclusion criteria
* Stroke or myocardial infarction less than 3 months prior to screening. * Presence of uncontrolled systolic blood pressure or diastolic blood pressure * Renal failure requiring dialysis or renal transplant or renal insufficiency * Untreated diabetes mellitus * Use of any systemic anti-VEGF drugs * Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening. * Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception For either eye: * Any active periocular or ocular infection or inflammation * Uncontrolled glaucoma * Neovascularization of the iris or neovascular glaucoma * History of treatment with any anti-angiogenic drugs For study eye: * Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline. * Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization or macular edema of any other cause than DME * Irreversible structural damage within 0.5 disc diameter of the center of the macula * Panretinal laser photocoagulation within 6 months prior to randomization. * Focal/grid laser photocoagulation within 3 months prior to randomization. * Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following * Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening. * Application of intravitreal corticosteroids in vitreous within 6 months prior to screening. Prior application of fluocinolonacetonid releasing implant in vitreous within 36 months prior to screening. For fellow eye \- Retinal or choroidal neovascularization or macula edema of any cause Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic VEGF-A protein levels | From baseline to study week 12 | Systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic VEGF-A protein levels | From study week 12 to 24 | Systemic VEGF-A protein levels in patients switching from monthly 2 mg aflibercept injections to monthly 0.5 mg ranibizumab compared to patients treated with 0.5 mg ranibizumab from baseline |
| Systemic VEGF-A levels | From study week 12 to 24 | Adjustment of systemic VEGF-A levels of patients switching from aflibercept to ranibizumab to levels comparable to baseline or to levels comparable as in patients treated from baseline with ranibizumab |
Countries
Germany
Outcome results
None listed