Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492400
• Other study ID #: 206207-024
• Status: Completed
• Phase: Phase 2
• Start date: March 9, 2012
• Est. completion date: February 13, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: February 13, 2014
• Est. primary completion date: February 13, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of type 1 or 2 diabetes mellitus

• Diagnosis of macular edema

• Visual acuity between 20/200 to 20/40

Exclusion Criteria:

• Eye surgery to the study eye within 3 months

• Use of Ozurdex® within 9 months

• Any active ocular inflammation and infection

• Diagnosis of glaucoma

• Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
• ranibizumab
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Israel,  Italy,  Netherlands,  Portugal,  South Africa,  Spain,  United Kingdom, 

References & Publications (1)

Callanan DG, Loewenstein A, Patel SS, Massin P, Corcóstegui B, Li XY, Jiao J, Hashad Y, Whitcup SM. A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2017 Mar;255(3):463-473. doi: 10.1007/s00417-016-3472-1. Epub 2016 Sep 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.	Baseline, 12 Months
Secondary	Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye	OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).	Baseline, Month 12
Secondary	Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)	FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).	Baseline, Month 12