A phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab (0.3 mg) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration - SUSTAIN

• Register: EUCTR
• Last refreshed on: 26 June 2012
• Main ID: EUCTR2005-005921-73-FI
• Date of registration: 21/06/2006
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Service AG
• Public title: A phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab (0.3 mg) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration - SUSTAIN
• Scientific title: A phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab (0.3 mg) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration - SUSTAIN
• Date of first enrolment: 07/08/2006
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005921-73
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium, Finland, Germany, Hungary, Italy, Netherlands, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent form
2. Male or female patients >50 years of age
3. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
4. The total area of CNV (including both classic and occult components) encompassed within the lesion must be ³ 50% of the total lesion area
5. The total lesion area must be = 12 disc areas
6. Patients who have a BCVA score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
7. Expectation by the investigator that patients will potentially benefit from ranibizumab treatment
Are the trial subjects under 18?
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Previous treatment with intravitreally (in either eye) or intravenously administered Avastin ™ (bevacizumab)
2. Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy (Visudyne®) or pegaptanib sodium (Macugen®) in the study eye within 30 days preceding Day 1
3. Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy.
4. History of surgical intervention in the study eye within two months preceding Day 1
5. Previous participation in any studies of investigational drugs within one month preceding Day 1(excluding vitamins and minerals and study CRFB002A2301)
6. Concurrent use of systemic anti-VEGF agents
7. Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine (Plaquenil), tamoxifen, phenothiazines and ethambutol
8. Concomitant use of chronic NSAIDs for more than seven consecutive days or systemic or topical ocular corticosteroids for three or more consecutive days within six months prior to screening) or at any time during the study. Note that ASA (aspirin) taken as “low dose” up to 100 mg qd for prophylaxis of myocardial infarction and/or stroke is permitted during study
9. Previous treatment with or participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate or corticosteroids, etc.).
10. Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment or macular hole (Stage 3 or 4), active intraocular inflammation (grade trace or above) or persistent macular edema due to uveitis or other inflammatory diseases
11. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period
12. Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
13. Presence of retinal pigment epithelial tear involving the macula in the study eye
14. History of idiopathic or autoimmune-associated uveitis in either eye
15. Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
16. History of glaucoma filtration surgery or corneal surgery
17. Extracapsular extraction of cataract with phacoemulsification within 2 months preceding Day 1, or a history of post-operative complications within the last 12 months preceding Day 1 in the study eye (uveitis, cyclitis etc.)
18. Uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma mediation).
19. Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
20. Spherical equivalent of the refractive error in the study eye demonstrating more than –8 diopters of myopia; for subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye can not exceed -8 diopters of myopia


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

Health Condition(s) or Problem(s) studied

Male and female patients =50 years of age with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)

Intervention(s)

Product Name: Lucentis
Product Code: RFB002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ranibizumab
Current Sponsor code: RFB002
Other descriptive name: rhuFab V2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)

Secondary Objective: Secondary objectives:
1. To evaluate the mean change in best corrected visual acuity (BCVA) from Baseline to Months 3 and 12.
2. To evaluate the mean change in retinal thickness as assessed with OCT from Baseline to Months 3 and 12.
3. To evaluate the time to the first retreatment and the total number of treatments.

Exploratory objectives:
1. To evaluate the interaction between edema reduction and the change/status of visual acuity to support establishment of edema reduction as a surrogate endpoint.

Primary end point(s): The primary objective of this study is to estimate the incidence of ocular adverse events (AEs) in patients with CNV secondary to AMD who are treated with 0.3 mg intravitreal ranibizumab.

Main Objective: The primary objective of this study is to estimate the incidence of ocular adverse events (AEs) in patients with CNV secondary to AMD who are treated with 0.3 mg intravitreal ranibizumab.

Secondary ID(s)

CRFB002A2303

2005-005921-73-ES