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

NCT ID: NCT02878681

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-09-30

Brief 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.

Detailed Description

The purpose of the study is to compare the effect of monthly intravitreal injections of 0.5 mg ranibizumab and 2.0 mg aflibercept on systemic VEGF levels in patients with visual impairment due to DME over a 24 week period. In addition, the study will also assess the effect on systemic VEGF-A levels when patients are switched from aflibercept to ranibizumab.

Conditions

Visual Impairment Due to Diabetic Macular Edema

Keywords

Diabetic Macular Edema.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Monthly intravitreal injections of 0.5 mg ranibizumab for six months

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

0.5 mg intravitreal injections

Group 2

Monthly intravitreal injections of 2 mg aflibercept for the initial three months followed by monthly intravitreal injections of 0.5 mg ranibizumab for the next three months.

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

0.5 mg intravitreal injections

Aflibercept

Intervention Type: DRUG

2 mg intravitreal injections

Group 3

Monthly injections of 2 mg aflibercept for six months

Group Type: EXPERIMENTAL

Aflibercept

Intervention Type: DRUG

2 mg intravitreal injections

Interventions

Ranibizumab

0.5 mg intravitreal injections

Intervention Type: DRUG

Aflibercept

2 mg intravitreal injections

Intervention Type: DRUG

Other Intervention Names

Lucentis; Eylea

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

CRFB002D2404

Identifier Type: -

Identifier Source: org_study_id