24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.

• Status: Withdrawn
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF levels in DME patients in a detailed time course.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Aflibercept; Ranibizumab

Criteria

Inclusion Criteria:

• Type 1 or Type 2 diabetes mellitus

• Visual impairment due to DME

• BCVA of 78 to 24 (20/32-20/320) ETDRS letters

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 within 6 months prior to screening.

• 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, rhegm

• 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/exclusion criteria may apply.