A 12-month study to evaluate the efficacy and safety of injections of 0.5mg ranibizumab into the eye of patients with vision loss caused byincreased accumulation of fluid within the intraretinal layers of the macula(macular edema) and for which ranibizumab may have a positive impact

• Conditions: Visual impairment due to vascular endothelial growth factor (VEGF)driven macular edema (ME); MedDRA version: 17.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-005418-20-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-20
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• Diagnosis of active ME secondary to any causes (for adult patients:
except DME, AMD and RVO) that is primary, chronic (i.e., ME is present
for > 3 months) or recurrent, confirmed by at least one of three
following criteria::
a) Presence of posterior pole changes compatible with active ME seen by
fundus ophthalmoscopy, biomicroscopy and fundus photography
b) Presence of leakage from ME seen by fluorescein angiography (FA)
c) Presence of intra-retinal fluid/cysts seen by optical coherence
tomography (OCT)
• BCVA must be between = 24 and = 83 letters tested at 4 meters
starting distance using ETDRS-like visual acuity charts (approximate
Snellen chart equivalents of 20/25 and 20/320) in the study eye
• Visual loss in the study eye should be mainly due to the presence of
any eligible types of ME (for adult patients: non-DME, non-AMD and non-
RVO) based on ocular clinical, as well as FA and OCT findings
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 157
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

For both eyes
• Active diabetic retinopathy, active ocular/periocular infectious disease
or active severe intra-ocular inflammation (e.g., anterior chamber cells
(ACC) >2+ and/or vitreous haze (VH) >2+). Rescreening is permitted
after intra-ocular inflammation is successfully treated with antiinflammatory
therapy that does not compromise eligibility
• Confirmed intraocular pressure (IOP) = 25 mmHg for any reason
• Neovascularization of the iris or neovascular glaucoma
• Inability to obtain fundus photographs, fluorescein angiograms or OCT
images of sufficient quality to be analyzed
For study eye
• ME secondary to DME, AMD or RVO (for adult patients only). RAP
lesions are exclusionary in patients 50 years of age or older
• Ocular disorders that could confound interpretation of study results,
compromise visual acuity or require medical or surgical intervention
during the 12-month study period. These include for example:
a. Presence or history of retinal detachment, macular hole, epi-retinal
membrane (if the membrane is involving the fovea)
b. Presence of cataract, leading to marked visual impairment and/or
requiring surgery during the study
c. Presence of vitreomacular traction (VMT) as the primary reason for
the ME in the opinion of the investigator
d. Diagnosis of retinitis pigmentosa (RP)
e. Diagnosis of Central Serous Chorioretinopathy (CSC, CSR)
• Any type of advanced, severe or unstable ocular disease or its
treatment, that could interfere with the primary and/or secondary
outcome evaluations including any medical condition that could be
expected to progress, recur, or change to such an extent that it could
bias the assessment of the clinical status of the patient to a significant
degree or put the patient at special risk.
• ME with a high likelihood of spontaneous resolution (e.g., central
serous chorioretinopathy (CSC) or pseudophakic ME) unless the ME
persists for > 3 months or has not improved upon topical treatment with
steroids or NSAIDsHistory of laser photocoagulation with involvement of
the macular area at any time
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• Verteporfin photodynamic therapy (vPDT) at any time
• History of intraocular treatment with any anti-angiogenic drugs within
6 months of the baseline visit (e.g., bevacizumab [Avastin®], aflibercept
[Eylea®], pegaptanib [Macugen®], ranibizumab [Lucentis®])
• History of intravitreal treatment with steroids, e.g. triamcinolone
within 6 months prior to baseline
• History of treatment with intravitreal implants (e.g., Illuvien®,
Ozurdex®, Retisert®) at any time
• History of vitreoretinal surgery at any time (cataract surgery is not an
exclusion criterion unless a large removal of vitreous or removal of
posterior vitreous has occurred)

Study & Design

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