Clinical trial NCT01377597: Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion
Official title: A 3-month, Phase III, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Monthly Intravitreal Injections as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Branch or Central Retinal Vein Occlusion (RVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinal Vein Occlusion
Keywords: retinal vein occlusion
branch retinal vein occlusion
central retinal vein occlusion
visual impairment
macular edema
ranibizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-21
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.


Eligibility criteria: Inclusion Criteria:

* Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1
* Best-corrected visual acuity (BCVA):
* CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
* BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2

Exclusion Criteria:

* Pregnant or nursing women
* History of stroke
* Uncontrolled blood pressure
* Active ocular infection or intraocular inflammation in either eye
* Uncontrolled glaucoma in either eye
* Neovascularization of the iris or neovascular glaucoma in either eye
* Prior episode of RVO more than 12 months prior to Visit 1 in the study eye
* Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2
* Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye
* Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye
* Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye
* Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye
* Use of any intra-ocular corticosteroid implants in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline
timeFrame: 3 months
Secondary outcomes:
measure: Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit
timeFrame: 3 months
measure: Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3
timeFrame: 3 months
measure: Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3
timeFrame: 3 months
measure: Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3
timeFrame: 3 months
measure: Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Ohtsu
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_DIRECTOR
References:
citation: Kamei M, Terasaki H, Yoshimura N, Shiraga F, Ogura Y, Grotzfeld AS, Pilz S, Ishibashi T. Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients. Acta Ophthalmol. 2017 Feb;95(1):e29-e35. doi: 10.1111/aos.13196. Epub 2016 Sep 22.