A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168324
• Other study ID #: 206207-008
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2004
• Est. completion date: October 1, 2008

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 an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: October 1, 2008
• Est. primary completion date: March 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older with macular edema resulting from retinal vein occlusion

• 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

• Diabetic retinopathy

• Uncontrolled systemic disease

• Known steroid-responder

• Use of systemic steroids

• Use of warfarin/heparin

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
• 350 µg Dexamethasone
350 µg Dexamethasone intravitreal implant administered on Day 0.

Other:
• Sham Injection
Sham injection on Day 0.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czechia,  France,  Germany,  Israel,  Mexico,  Philippines,  Portugal,  South Africa,  Taiwan, 

References & Publications (1)

Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Response Rate of 15 or More Letter Improvement	The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.	Up to 180 Days
Secondary	Number of Patients With 15 or More Letter Improvement 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). 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 means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.	Day 90, Day 180
Secondary	Change From Baseline in Retinal Thickness in the Study Eye	Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.	Baseline, Day 90, Day 180
Secondary	Percentage of Patients With a Change From Baseline in BCVA by Category	BCVA is measured 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 means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: =15 Letters Improvement, =5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), =5 and <15 Letters Worsening, and =15 Letters Worsening.	Baseline, Day 90
Secondary	Percentage of Patients With a Change From Baseline in BCVA by Category	BCVA is measured 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 means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: =15 Letters Improvement, =5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), =5 and <15 Letters Worsening, and =15 Letters Worsening.	Baseline, Day 180