Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464685
• Other study ID #: 206207-012
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2007
• Est. completion date: February 8, 2010

Study information

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

Clinical Trial Summary

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: February 8, 2010
• Est. primary completion date: February 8, 2010
• 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

• Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)

• Visual acuity in other eye no worse than 20/200

Exclusion Criteria:

• Known anticipated need for ocular surgery within next 12 months

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

• Uncontrolled systemic disease

• Known steroid-responder

• Use of systemic steroids - Use of Warfarin/Heparin

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Dexamethasone
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.
• Sham injection
Initial sham injection with up to 1 additional treatment based on re-treatment criteria.

Procedure:
• Laser Photocoagulation
Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Callanan DG, Gupta S, Boyer DS, Ciulla TA, Singer MA, Kuppermann BD, Liu CC, Li XY, Hollander DA, Schiffman RM, Whitcup SM; Ozurdex PLACID Study Group. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013 Sep;120(9):1843-51. doi: 10.1016/j.ophtha.2013.02.018. Epub 2013 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (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, Month 12
Secondary	Change From Baseline in 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 in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.	Baseline, Month 12
Secondary	Change From Baseline in Central Subfield Retinal Thickness in the Study Eye	Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). 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 number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.	Baseline, Month 12
Secondary	Change From Baseline in the Focal Leakage Area in the Study Eye	Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.	Baseline, Month 12
Secondary	Time to Retreatment in the Study Eye	Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.	12 Months