A Six-Month Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial (with Six-Month Open-Label Extension) to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Macular Edema following Central Retinal Vein Occlusion or Branch Retinal Vein Occlusion.
- Conditions
- Macular edema due to Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO)
- Registration Number
- EUCTR2004-002502-29-GB
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
1. Male or female, at least 18 years of age
2. Macular edema in the study eye with all of the following characteristics:
-involving the center of the macula (fovea)
-due to BRVO or CRVO
-with a duration of 6 weeks to 9 months prior to qualification/baseline visit for
CRVO patients and a duration of 6 weeks to 12 months prior to
qualification/baseline visit for BRVO patients
-VA decrease attributable to the edema
-in the investigator’s opinion, unlikely to be adversely affected if not treated for 6
months
3. BCVA score between 34 letters (approximately 20/200 Snellen equivalent) and 68
letters (approximately 20/50 Snellen equivalent) in the study eye measured by the
ETDRS method at qualification/baseline
4. Retinal thickness of = 300 µm by OCT in the central 1 mm macular subfield of
the study eye at qualification/baseline as determined by the investigator
5. Female patients of childbearing potential must have a negative urine pregnancy
test at the randomization (day 0) visit
6. Written informed consent has been obtained
7. Written Authorization for Use and Release of Health and Research Study
Information (US sites only) has been obtained
8. Written Data Protection Consent (European sites only) has been obtained
9. Written documentation has been obtained, in accordance with state and country
privacy requirements, where applicable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Uncontrolled systemic disease
2. Any ocular condition in the study eye that, in the opinion of the investigator,
would prevent a 15-letter improvement in visual acuity (eg, severe macular
ischemia)
3. Presence of an epiretinal membrane in the study eye which, in the opinion of the
investigator, is the primary cause of macular edema, or is severe enough to
prevent improvement in visual acuity despite reduction in macular edema
4. History of IOP elevation in response to steroid treatment in either eye that
resulted in any of the following:
1) a = 10 mm Hg increase in IOP from baseline;
2) IOP = 25 mm Hg; or
3) required therapy with anti-glaucoma medications
5. History of glaucoma or optic nerve head change consistent with glaucoma
damage, and/or glaucomatous visual field loss in the study eye. Patients with a
history of previous angle-closure that has been successfully treated with either a
laser or surgical peripheral iridotomy (PI) are allowed as long as the visual fields
have been stable for > 1 year prior to study entry and the patient has been and can
be safely dilated.
6. Ocular hypertension in the study eye at qualification/baseline with any of the
following:
1) IOP > 23 mm Hg if taking no anti-glaucoma medications;
2) IOP > 21 mm Hg if taking one anti-glaucoma medication; or
3) use of 2 or more anti-glaucoma medications (combination products should be
considered 2 medications)
Note: Anti-glaucoma medications or lack thereof must be stable for at least 4
weeks prior to qualification/baseline.
7. Aphakia or presence of anterior chamber intraocular lens in the study eye
8. Diabetic retinopathy in either eye
9. Active or history of choroidal neovascularization in the study eye
10. Presence of rubeosis iridis in the study eye at qualification/baseline
11. Any active ocular infection (ie, bacterial, viral, parasitic, or fungal) in either eye
at qualification/baseline
12. History of herpetic infection in the study eye or adnexa
13. Presence of active or inactive toxoplasmosis in either eye at qualification/baseline
14. Presence of visible scleral thinning or ectasia in the study eye at
qualification/baseline
15. Intraocular surgery, including cataract surgery, and/or laser of any type in the
study eye within 90 days prior to qualification/baseline
16. History of central serous chorioretinopathy in either eye
17. History of pars plana vitrectomy in the study eye
18. History of use of intravitreal steroids or any intravitreal injectable drug in the
study eye
19. Periocular depot of steroids to the study eye within 6 months prior to
qualification/baseline
20. Use of systemic steroids (e.g., oral, intravenous, intra-articular, epidural, intrabursal) within 1 month prior to qualification/baseline visit or anticipated use at
any time during the study. Inhaled and intranasal steroids are allowed.
21. Use of topical or systemic carbonic anhydrase inhibitors (e.g., Azopt®, Trusopt®,
Diamox®) within 1 month prior to qualification/baseline visit or anticipated use at
any time during the study
22. Use of immunosuppressants, immunomodulators, antimetabolites, and/or
alkylating agents use within 6 months prior to qualification/baseline or anticipated
use at any time during the study
23. Use of topical ophthalmic steroids or topical non-steroidal anti-inflammatory
drugs (NSAIDs) within 1 month prior to qualification/baseline or anticipated use
within the 12-month study period in the study eye
24. Use of warfarin, hep
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method