The primary objective is to evaluate the efficacy of an individualized stabilization criteriadrivenPRN dosing regimen with 0.5 mg ranibizumab as assessed by the mean best-corrected visualacuity (BCVA) change at Month 12 compared to Baseline.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy variable is the mean change in BCVA at Month 12 compared
to Baseline.
Secondary outcome
Secondary efficacy endpoints related to the mean change from Baseline will be
assessed as per the primary efficacy endpoint. For more information about the
secondary study parameters/outcomes please refer to protocol (v00 26May2011)
page 42.
Background summary
The present study will provide additional efficacy and safety data for 0.5-mg
ranibizumab using PRN dosing over 24 months in patients with visual impairment
due to macular edema secondary to CRVO. Spectral domain high-definition optical
coherence tomography (OCT) images will be analyzed to gain insights into
predictive factors for disease progression and the possibility of reduced
monitoring will be assessed in Year 2. The results of this open-label study
will provide long-term safety and efficacy data to further guide
recommendations on the use of ranibizumab in this indication.
Study objective
The primary objective is to evaluate the efficacy of an individualized
stabilization criteriadriven
PRN dosing regimen with 0.5 mg ranibizumab as assessed by the mean
best-corrected visual
acuity (BCVA) change at Month 12 compared to Baseline.
Study design
Phase IIIb, open-label, single arm, multicenter study. In addition to Screening
and Baseline, there will be a visit on Day 8 followed by monthly visits from
Month 1 to Month 12. In
Year 2, 12 monthly visits may occur, but the possibility to skip visits may
reduce this number.
Intervention
The investigational treatment is 0.5 mg ranibizumab administered PRN by
intravitreal injections.
Study burden and risks
Assuming a patient with maximal study treatment during the whole study (2
years):
27 times vital functions, ETDRS BCVA (visus sharpness), Ophthalmic examination,
tonometry, OCT scan
25 times Color fundus photography, Fluorescein angiography
6 times NEI-VFQ-25 (questionnaire)
Ranibizumab can have the following side-effects:
Very common (10 or more in every 100 patients): bloodshot eye, eye pain, small
particles or spots in your vision, bleeding in the back of the eye, increased
eye pressure, displacement of the jelly-like portion inside the eye, troubling
of (a part of) the lens, inflammation of the eye, eye irritation, a feeling of
having something in the eye, visual disturbance, inflammation or infection of
the eyelid margins, formation of fibrous tissue under the retina, redness of
the eye, itching of the eye, dry eye, inflammation of the jelly-like portion
inside the eye, headache, runny nose and sore throat, back pain, pains in the
joints, elevated blood pressure, and decreasing number of red blood cells and
nausea.
Common (between 1 and 10 in every 100 patients): discomfort of the eye,
deposits in the back of the eye, bleeding at the site of the injection into the
eye, infection of the surface of the eye, infection of the eyeball, changes in
the part of the retina responsible for central vision, degeneration of the
retina, detachment of or rip in the retina or a layer of the retina causing
flashes of light with floaters and shadows progressing to a loss of sight,
blurred or decreased sharpness of vision, inflammation of the colored part of
the eye, the radial body (corpus ciliare) or an internal part of the eye,
little spots on the surface of the eye, bleeding of the eye, scratch or
inflammation of the cornea, increasing production of tears, discharge of the
eye with itching, redness and swelling, swelling of the eyelid, eyelid pain,
and sensitivity to light, infection of the lower part of the airways, flu,
urinary tract infection, stroke, anxiety, cough, and allergic reactions.
Uncommon (less than 1 in every 100 patients): changes in or thickening or
thinning of the central part of the surface of the eye, disorder in the back of
the eye or the jelly-like portion inside the eye, a specific type of glaucoma,
blindness, inflammatory deposits in the front part of the eye, pain or
irritation at the site of injection, abnormal sensation in the eye, irritation
of the eyelid, and accumulation of blood in the front part of the eye,
wheezing, increased secretion of the upper airways, changes in heart rhythm,
and inflammatory disease of the skin.
Finally, there are risks related to the procedures performed for study
purposes; the injection procedures and/or additional research procedures.
Lichtstrasse 35
Basel 4002
CH
Lichtstrasse 35
Basel 4002
CH
Listed location countries
Age
Inclusion criteria
1. Male or female patients must be at least 18 years of age
2. Diagnosis of visual impairment exclusively due to ME secondary to central retinal vein
occlusion (CRVO)
3. BCVA-sore at Screening and Baseline must be between 73 and 19 letters
Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen
chart equivalent of 20/40 and 20/400)
Exclusion criteria
1. Stroke or myocardial infarction less than 3 months prior to Screening
2. Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of
>100 mm Hg at Screening or Baseline. Antihypertensive treatment can be initiated and has to
be taken for at least 30 days after which the patient can be assessed for study eligibility a
second time
3. Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis,
keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye
4. Uncontrolled glaucoma (intraocular pressure [IOP] >=30 mm Hg on medication or according to
investigator*s judgment) at Screening or Baseline or diagnosed within 6 months prior to
Baseline in either eye
5. Neovascularization of the iris or neovascular glaucoma in either eye
6. Use of any systemic anti-vascular endothelial growth factor (VEGF) drugs within 6 months
prior to Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
7. Prior treatment with any anti-angiogenic drugs (including any anti-VEGF agents) within
3 months prior to Baseline in either eye (eg, pegaptanib [Macugen®], ranibizumab [Lucentis®],
bevacizumab [Avastin®])
8. Panretinal laser photocoagulation within 3 months prior to Baseline or anticipated or
scheduled within the next 3 months following Baseline in the study eye
9. Focal or grid laser photocoagulation within 4 months prior to Baseline in the study eye
10. Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months prior to
Screening in the study eye
11. Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone
acetonide [Iluvien®]) in the study eye
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002350-31-NL |
| ClinicalTrials.gov | NCT01535261 |
| CCMO | NL38012.058.11 |