Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799227
• Other study ID #: 206207-018
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2009
• Est. completion date: December 1, 2009

Study information

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

Clinical Trial Summary

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 1, 2009
• Est. primary completion date: December 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older with diabetic macular edema

• History of vitrectomy

• Central retinal thickness = 275 µm

• Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion Criteria:

• Known anticipated need for ocular surgery during the study period

• History of glaucoma or current high eye pressure requiring more than 1 medication

• Uncontrolled systemic disease

• Known allergy to the study medication

• Known steroid-responder

• Use of systemic steroids

• Female subjects that are pregnant, nursing or planning a pregnancy

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema
• Vitrectomy

Intervention

Drug:
• Dexamethasone
700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (1)

Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Central Retinal Thickness in the Study Eye	Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.	Baseline, Week 26
Secondary	Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.	Baseline, Week 26
Secondary	Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.	Baseline, Week 26
Secondary	Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye	Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased = 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased = 10%).	Baseline, Week 26