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

NCT02878681 | Withdrawn Phase 4

• 1 other identifier: CRFB002D2404
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Visual Impairment Due to Diabetic Macular Edema

Keywords

Diabetic Macular Edema.

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of VEGF-A levels from baseline to week 24

  Systemic VEGF-A levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve) expressed in pg/ml\*days. The AUC will be standardized (=divided) by the individual follow-up time and will be calculated by the trapezoidal rule..

  baseline to week 24

Secondary Outcomes (3)

• Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 2 within specific time points

  Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24

• Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 3 within specific time points

  Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24

• Proportion of patients reporting ocular and/or systemic adverse events in all the three treatment groups.

  From Baseline to Week 24

Study Arms (3)

Group 1

EXPERIMENTAL

Monthly intravitreal injections of 0.5 mg ranibizumab for six months

Drug: Ranibizumab

Group 2

EXPERIMENTAL

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.

Drug: Ranibizumab; Drug: Aflibercept

Group 3

EXPERIMENTAL

Monthly injections of 2 mg aflibercept for six months

Drug: Aflibercept

Interventions

Ranibizumab DRUG

0.5 mg intravitreal injections

Also known as: Lucentis

Group 1; Group 2

Aflibercept DRUG

2 mg intravitreal injections

Also known as: Eylea

Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or Type 2 diabetes mellitus
• Visual impairment due to DME
• BCVA of 78 to 24 (20/32-20/320) ETDRS letters

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

Ranibizumab; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 25, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 28, 2017

Record last verified: 2017-04