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: 25 November 2019
• Main ID: EUCTR2005-005921-73-GB
• Date of registration: 03/03/2006
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services 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: 01/04/2006
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patients =50 years of age
2. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
3. The total area of CNV (including both classic and occult components) encompassed within the lesion must be =50% of the total lesion area
4. The total lesion area must be = 12 disc areas
5. 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)
6. Expectation by the investigator that patients will potentially benefit from ranibizumab treatment
7.Willing and able to give written informed consentaccording to legal requirements, and who have signed the consent form prior to intiation of any study procedure.
8. Willing and able to comply with all study procedures.
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
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)
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, compromise visual acuity or require medical or surgical intervention during the 12-month study period (see protocol for more information)
11. History of idiopathic or autoimmune-associated uveitis in either eye
12. History of glaucoma filtration surgery or corneal surgery
13. 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.)
14. Uncontrolled glaucoma in the study eye (defined as intraocular pressure > or = 25 mmHg despite treatment with anti-glaucoma medication).
15. Aphakia (no lens) or absence of the posterior capsule in the study eye.
16. 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.
17. Patients with angioid streaks or presursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma or pathologic myopia
18. Patients who have BCVA of <34 letters in both eyes
19. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
20. Evidence of significant uncontrolled concomitant diseases such

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)

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.

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.

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)

2005-005921-73-ES

CRFB002A2303

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 31/03/2016
• Date Completed: 18/04/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-005921-73/results