Systemic VEGF Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Visual Impairment Due to Diabetic Macular Edema Clinical Trial

— TIDE DME  

Official title:

A Randomized, Single-blinded, Multicenter, Phase IV Study to Compare Systemic VEGF Protein Dynamics Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Study Week 12 in Patients With Visual Impairment Due to Diabetic Macular Edema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02258009
• Other study ID #: CRFB002DDE25
• Status: Withdrawn
• Phase: Phase 4
• First received: October 2, 2014
• Last updated: October 26, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Vision Disorders
• Visual Impairment Due to Diabetic Macular Edema

Intervention

Drug:
• Ranibizumab
0.5 mg intravitreal injections
• Aflibercept
2 mg intravitreal injections

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Chemnitz

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic VEGF-A protein levels	Systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve)	From baseline to study week 12	No
Secondary	Systemic VEGF-A protein levels	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	From study week 12 to 24	No
Secondary	Systemic VEGF-A levels	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	From study week 12 to 24	No