Efficacy and safety of two different treatment patterns of ranibizumab in patients with wet AMD

• Register: EUCTR
• Last refreshed on: 26 October 2015
• Main ID: EUCTR2011-004959-39-ES
• Date of registration: 06/03/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A.
• Public title: Efficacy and safety of two different treatment patterns of ranibizumab in patients with wet AMD
• Scientific title: A 24-month, phase IIIb, randomized, double-masked, multicenter study assessing the efficacy and safety of two treatment regimens of 0.5 mg ranibizumab intravitreal injections guided by functional and/or anatomical criteria, in patients with neovascular age-related macular degeneration (OCTAVE) - OCTAVE
• Date of first enrolment: 19/04/2013
• Target sample size: 670
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004959-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Lucentis Number of treatment arms in the trial: 2

Countries of recruitment

Argentina, Austria, Brazil, Canada, Colombia, Czech Republic, Finland, France, Germany, Greece, Guatemala, Hungary, Ireland, Italy, Lithuania, Mexico, Netherlands, Panama, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Venezuela, Bolivarian Republic of

Contacts

• Name: Departamento Médico (ICRO)
• Affiliation: Novartis Farmacéutica, S.A.

• Name: Departamento Médico (ICRO)
• Affiliation: Novartis Farmacéutica, S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria for patient
- Male or female patients, ?50 years of age.

Inclusion criteria for study eye
- Visual impairment predominantly due to neovascular AMD
- Active, newly diagnosed, untreated, angiographically documented, CNV lesion secondary to AMD
- CNV or sequelae of the CNV involving the center of the fovea.
- The total area of fibrosis comprising less than 50% of the lesion area.
- BCVA score at both Screening and Baseline between 78 and 23 letters as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at 4 meters, inclusively (approximate Snellen equivalent of 20/32 and 20/320).
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion criteria:
Exclusion criteria for systemic medical history and conditions
- Stroke or myocardial infarction less than 3 months prior to Screening.

Exclusion criteria for ocular medical history and conditions
For either eye
- Any active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of Screening or Baseline.
- Uncontrolled glaucoma (intraocular pressure [IOP] ?30 mm Hg on medication or according to investigator?s judgment) at the time of Screening or Baseline.

For study eye
- Cataract (if causing significant visual impairment), aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wet AMD (e.g., ocular histoplasmosis, pathologic myopia) at the time of Screening and Baseline.

- Irreversible structural damage within 0.5 disc diameter of the center of the macula (e.g., vitreomacular traction, epiretinal membrane, scar, laser burn, macular hole) at the time of Screening and Baseline that in the investigator?s opinion could preclude visual function improvement with treatment.
Exclusion criteria for prior or current ocular treatment

For either eye
- Treatment with any anti-angiogenic drugs (including any anti-VEGF agents) within 3 months prior to Baseline in either eye (e.g., bevacizumab [Avastin®]).

For study eye
- Any intraocular procedure (including Yttrium-Aluminum-Garnet capsulotomy) within 2 months prior to Baseline or anticipated within the next 6 months following Baseline.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Visual impairment due to neovascular AMD
MedDRA version: 15.1 Level: LLT Classification code 10060837 Term: Choroidal neovascularization System Organ Class: 100000004853

Intervention(s)

Trade Name: Lucentis. Se trata de medicación comercial, que se acondiciona para su uso en el Ensayo Clínico.
Product Name: Lucentis
Product Code: RFB002A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Primary end point(s): Average Visual Acuity change from Month 3 to Month 4 through Month 12

Main Objective: The primary objective is to evaluate the effectiveness of two treatment regimens by assessing the average BCVA change from Month 4 to Month 12 compared to Month 3 based on both, BCVA stability in each treatment group and comparison of the two treatment groups. For the analysis of these objectives a reference margin of two letters will be applied.
A treatment regimen will be considered a relevant option if stability is achieved and non-inferiority compared to the other group is demonstrated.

Secondary Objective: To evaluate the efficacy of the two treatment regimens by assessing
?time course of BCVA from baseline (BL),
?improvement of BCVA ?1, ?5, ?10, and ?15 letters from BL, at M12 and 24,
?loss of BCVA <5, <10, and <15 letters from BL, at M12 and 24,
?BCVA ?73 letters at M12 and 24,
?average BCVA change from M4 to M24 compared to M3,
?average BCVA change from M1 to M12, and to M24 compared to BL.
To assess treatment exposure and patterns of the two treatment regimens over time based on
?frequency,
?reason,
?compliance
?duration of treatment-free intervals
?duration of active treatment-phases.
To evaluate the retinal anatomy by
?change in central subfield retinal thickness and central subfield volume from BL, over time,
?proportion of patients achieving a dry retina at M12 and M24,
?change in lesion size and morphology at M12 and M24.
To evaluate the change in VFQ-25 composite and subscale scores over time.
To evaluate the safety of ranibizumab over 12 and 24 months.

Timepoint(s) of evaluation of this end point: Month 3 to Month 12

Secondary Outcome(s)

Secondary end point(s): Change from Baseline in Visual Acuity (Letters) of the Study Eye over time

Gain of equal or more than 1, 5, 10, or 15 letters in Visual Acuity of the Study Eye from baseline, at Month 12/24

Loss of more than 5, 10, and 15 letters in Visual Acuity in the Study Eye from baseline, at Month 12/24

Visual Acuity of 73 letters or more in the Study Eye at Month 12/24

Average Visual Acuity change from Month 3 to Month 4 through Month 24 in the Study Eye

Average Visual Acuity change from baseline to Month 1 through Month 12/24 in the Study Eye

Change from Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye over time

Dry retina in the Study Eye on OCT at Month 12/24

Change from baseline in lesion size and morphology based on fluorescein angiography at Month 12/24

Treatment patterns over time in both treatment arms

Change from Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) scores over time

Frequency and severity of ocular and non-ocular adverse events over time

Timepoint(s) of evaluation of this end point: Baseline to Month 12/24
Month 12/24
Month 3 to Month 24
Screening to Month 12/24

Secondary ID(s)

2011-004959-39-CZ

CRFB002A2405

Source(s) of Monetary Support

Novartis Pharma Services AG