A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
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| ClinicalTrials.gov Identifier: NCT00168337 |
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Recruitment Status :
Completed
First Posted : September 15, 2005
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Brief Summary:
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Macular Edema | Drug: Dexamethasone Other: Sham | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 554 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 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. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
- Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Month 39/Final Visit ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 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
Information from the National Library of Medicine
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): NCT00168337
Locations
| United States, California | |
| Artesia, California, United States | |
| Brazil | |
| Sao Paulo, Brazil | |
| Canada, Ontario | |
| Mississauga, Ontario, Canada | |
| Colombia | |
| Bogota, Colombia | |
| France | |
| Dijon, France | |
| Hungary | |
| Budapest, Hungary | |
| India | |
| New Delhi, India | |
| Italy | |
| Milano, Italy | |
| Korea, Republic of | |
| Seoul, Korea, Republic of | |
| New Zealand | |
| Auckland, New Zealand | |
| Poland | |
| Warszawa, Poland | |
| Singapore | |
| Singapore, Singapore | |
| Taiwan | |
| Taipei, Taiwan | |
| United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00168337 |
| Other Study ID Numbers: |
206207-011 |
| First Posted: | September 15, 2005 Key Record Dates |
| Results First Posted: | August 4, 2014 |
| Last Update Posted: | August 4, 2014 |
| Last Verified: | July 2014 |
Additional relevant MeSH terms:
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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 |