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

Primary Purpose

Visual Impairment Due to Diabetic Macular Edema

Status

Withdrawn

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Ranibizumab

Aflibercept

About this trial

This is an interventional treatment trial for Visual Impairment Due to Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

Monthly intravitreal injections of 0.5 mg ranibizumab

Three monthly intravitreal injections of 2 mg aflibercept followed by three monthly intravitreal injections of 0.5 mg ranibizumab

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02258009

First Posted

October 2, 2014

Last Updated

October 26, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02258009

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Withdrawn

Study Start Date

October 2015 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Visual Impairment Due to Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Monthly intravitreal injections of 0.5 mg ranibizumab

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Three monthly intravitreal injections of 2 mg aflibercept followed by three monthly intravitreal injections of 0.5 mg ranibizumab

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

0.5 mg intravitreal injections

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Other Intervention Name(s)

Eylea

Intervention Description

2 mg intravitreal injections

Primary Outcome Measure Information:

Title

Systemic VEGF-A protein levels

Description

Systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve)

Time Frame

From baseline to study week 12

Secondary Outcome Measure Information:

Title

Systemic VEGF-A protein levels

Description

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

Time Frame

From study week 12 to 24

Title

Systemic VEGF-A levels

Description

Time Frame

From study week 12 to 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceutical

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09113

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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