Comparison of Ozurdex versus Lucentis in the treatment of BranchRetinal Vein Occlusion.
- Conditions
- Macula oedema secondary to branch retinal vein occlusion.MedDRA version: 14.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.0Level: PTClassification code 10038907Term: Retinal vein occlusionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2010-023900-29-ES
- Lead Sponsor
- Allergan Pharmaceuticals Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 307
1. Male or female, ? 18 years of age
2. Written informed consent has been obtained
3. Written Data Protection Consent (European sites only) has been
obtained
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 more or equal 320 ?m as assessed with Spectralis
optical coherence tomography (OCT) or more or equal 300 ?m 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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
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. Aphakia in the study eye or violation of the posterior capsule in the
stu
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable.;Primary end point(s): The primary efficacy variable is mean change in BCVA at month 12.;Timepoint(s) of evaluation of this end point: BCVA assessment at screening, baseline, day 7 and at each monthly visit.;Main Objective: To compare the efficacy and safety of Ozurdex vs. Lucentis in subjects with BRVO.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Mean change in the central retina subfield thickness between baseline<br>and month 6, and between baseline and month 12<br>2. Proportion of subjects with ? 15-letter improvement in BCVA between<br>baseline and month 12<br>3. Proportion of subjects with ? 15-letter decrease in BCVA between<br>baseline and month 12<br>4. Change from baseline in vision-dependent subfields of the VFQ-25<br>questionnaire including near vision, far vision, and vision-dependent<br>activity at month 3, month 6, and month 12.;Timepoint(s) of evaluation of this end point: 1. OCT assessments that will be used in evaluation of timepoint will be<br>done at baseline, month 6 and month 12.<br>2. and 3. BCVA assessments that will be used in evaluation of timepoints<br>will be done at baseline and month 12.<br>4. VFQ-25 questionnaire completed at baseline, month 3, month 6, and<br>month 12.