Comparison of Ozurdex versus Lucentis in the treatment of Branch Retinal Vein Occlusio

• Conditions: Macula oedema secondary to branch retinal vein occlusion; MedDRA version: 17.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: PTClassification code 10038907Term: Retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-023900-29-DE
• Lead Sponsor: Allergan Pharmaceuticals Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-29
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

1. Male or female, = 18 years of age
2. Written informed consent has been obtained
3. No inclusion criterion associated with this number
4. Study eye must have clear ocular media and adequate pupil dilation to permit good quality photographic imaging
5. ME secondary to BRVO in the study eye with all of the following characteristics:
a) involving the centre of the macula (fovea)
b) central retina subfield thickness = 320 µm as assessed with Spectralis optical coherence tomography (OCT) or = 300 µm as assessed with Cirrus OCT
c) less than 90 days from onset of BRVO symptoms to screening visit
d) visual acuity (VA) decrease attributable to retinal oedema
Note: Characteristics a and b will be confirmed by a CRC
6. Absence of severe macular ischemia (defined as an area of nonperfusion > 4 disc areas [DA] which involve the foveal avascular zone), as confirmed by a CRC
7. BCVA score of = 20 to = 70 letters (20/40 to 20/400 Snellen equivalent) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol at both the screening visit and day 1 visit.
8. Female subjects of childbearing potential must have a negative urine pregnancy test at the screening (day -14) visit.
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 154
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 154

Exclusion Criteria

1. History of a medical condition (disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that, in the opinion of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of study medication.
2. Ocular hypertension unless controlled with monotherapy.
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine (human chorionic gonadotropin [hCG] > 20 mIU/ml) or serum pregnancy test (hCG = 5 mIU/ml).
4. Pre-menopausal women of child-bearing potential not using adequate contraception. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant. This includes women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means unless they meet the following definition of postmenopausal:12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels of > 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy. Adequate
contraception is defined as one or more of the following methods: surgical sterilization (eg, bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, or cervical cap). Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and
withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after the administration of the last study drug injection.
Note: Instruct females of childbearing potential to immediately inform the investigator if they become pregnant during the study. Should this occur, the investigator shall immediately contact the Sponsor as detailed in Sections 9.2 and 9.3 of the protocol.
5. Participation in an investigational drug or device study within 30 days of the screening visit
6. Any current or history of ocular disease in the study eye other than RVO that, in the opinion the investigator, may confound assessment of the macula or affect central vision, such as exudative age-related macular degeneration, geographic atrophy, diabetic retinopathy, uveitis, angioid streaks, histoplasmosis, pathological myopia, retinal detachment, epiretinal membrane, macular hole, or significant cataract
7. History of cataract surgery in either eye within the past 3 months prior to the screening visit
8. History or evidence of serious ocular trauma or intraocular surgery (such as laser-assisted in situ keratomileusis, keratoplasty, vitrectomy) in the study eye within the past 6 months prior to the screening visit
9. History of severe or serious hypersensitivity to any components of the test article or fluorescein dye.
10. > 10-Letter improvement in BCVA between the screening visit and day 1
11. Brisk afferent pupillary defect (ie, obvious and unequivocal)
12. Aphakic study eye with rupture of the posterior lens capsul

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified