A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
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ClinicalTrials.gov Identifier: NCT00168389 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
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Condition or disease | Intervention/treatment | Phase |
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Diabetic Macular Edema | Drug: Dexamethasone Other: Sham | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 494 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |
Arm | Intervention/treatment |
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Experimental: Dexamethasone 700 μg
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
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Drug: Dexamethasone
350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Other Names:
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Experimental: Dexamethasone 350 μg
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
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Drug: Dexamethasone
350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Other Names:
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Sham Comparator: Sham
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
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Other: Sham
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months. |
- Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye [ Time Frame: Baseline, Month 39/Final Visit ]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). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
- Average Change From Baseline in BCVA in the Study Eye [ Time Frame: Baseline, 39 Months ]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.
- Change From Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Month 39/Final Visit ]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). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
- Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye [ Time Frame: Baseline, Month 39/Final Visit ]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). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
- Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, 39 Months ]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. The average OCT retinal thickness is calculated across study visits for each patient. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
- 10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye [ Time Frame: Baseline, 39 Months ]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). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.
- Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit ]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). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key 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
Key Exclusion Criteria:
- Known anticipated need for ocular surgery within first 12 months of study;
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168389
United States, California | |
Inglewood, California, United States | |
Australia, New South Wales | |
Westmead, New South Wales, Australia | |
Canada, Ontario | |
Toronto, Ontario, Canada | |
Czech Republic | |
Prague, Czech Republic | |
Germany | |
Hamburg, Germany | |
Israel | |
Tel Aviv, Israel | |
Philippines | |
Rockwell Center, Makati, Philippines | |
Portugal | |
Coimbra, Portugal | |
South Africa | |
Cape Town, South Africa | |
Spain | |
Barcelona, Spain |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT00168389 |
Other Study ID Numbers: |
206207-010 |
First Posted: | September 15, 2005 Key Record Dates |
Results First Posted: | August 4, 2014 |
Last Update Posted: | August 4, 2014 |
Last Verified: | July 2014 |
Macular Edema Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Dexamethasone Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |