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

Phase 1

• Conditions: Visual impairment due to vascular endothelial growth factor (VEGF) driven macular edema (ME); MedDRA version: 18.1 Level: PT Classification code 10025415 Term: Macular oedema System Organ Class: 10015919 - Eye disorders; MedDRA version: 18.1 Level: PT Classification code 10047571 Term: Visual impairment System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-13
• Study Completion: 2015-09-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 178

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::
• Presence of posterior pole changes compatible with active ME seen by fundus
ophthalmoscopy, biomicroscopy and fundus photography
• Presence of leakage from ME seen by fluorescein angiography (FA)
• 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 anti-inflammatory 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:
• Presence or history of retinal detachment, macular hole, epi-retinal membrane (if the
membrane is involving the fovea)
• Presence of cataract, leading to marked visual impairment and/or requiring surgery
during the study
• Presence of vitreomacular traction (VMT) as the primary reason for the ME in the
opinion of the investigator
• Diagnosis of retinitis pigmentosa (RP)
• 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
• 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

Study & Design

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