Other Clinical Trial - Systemic VEGF Protein Dynamics Following

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

Visual Impairment Due to Diabetic Macular Edema Clinical Trial

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 Description

n/a

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

See also
	Status	Clinical Trial	Phase
	Withdrawn	`NCT02878681` - 24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.	Phase 4
	Terminated	`NCT01131585` - Safety and Efficacy of Ranibizumab in Diabetic Macular Edema	Phase 3

See also

Status

Clinical Trial

Phase

Withdrawn

NCT02878681 - 24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.

Phase 4

Terminated

NCT01131585 - Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02258009
Study type	Interventional
Source	Novartis
Contact
Status	Withdrawn
Phase	Phase 4
Start date	October 2015
Completion date	October 2016

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms