Male and female patients =50 years of age with either with predominantly classic, minimally classic, or occult lesions with no classic component, all with primary or recurrent subfoveal CNV secondary to age-related macular degeneration.
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients 50 years of age or greater. 2. Patients with primary or recurrent subfoveal 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 ³ 50% of the total lesion area. 4. The total lesion area = 12 disc areas for minimally classic or occult with no classic component and = 9 disc areas (5400µm) in greatest linear dimension with predominately classic lesions. 5. Patients who have a BCVA score between 73 and 24 letters (approximately 20/40 to 20/320), inclusively, in the study eye. 6. Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure. 7. Willing and able to comply with all study procedures. 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
Exclusion criteria: 1. Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy. 2. History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery. 3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline. 4. Patients with angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia. 5. Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.). 6. History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma medication). 7. Aphakia with absence of the posterior capsule in the study eye. 8. Active intraocular inflammation (grade trace or above) in the study eye. 9. Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye. 10. Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye. 11. Presence of a retinal pigment epithelial tear involving the macula in the study eye. 12. Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ³ 50% of the total lesion area or ³ 1 disc area in size. 13. Subfoveal fibrosis or atrophy in the study eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the non-inferiority of two dosing regimens of ranibizumab administered as three consecutive monthly injections followed by quarterly injections (alternative dosing) compared to ranibizumab administered monthly (monthly dosing) as determined by the mean change in best-correct visual acuity (BCVA) from Baseline to Month 12 as assessed with ETDRS-like VA charts at an initial distance of four meters. ;Secondary Objective: Key secondary objectives: 1. To evaluate the safety and tolerability of alternative dosing versus monthly dosing by comparing rates of adverse events and serious adverse events, as well as changes in laboratory values and vital signs at Month 12 and 24. 2. To evaluate the effects of alternative dosing versus monthly dosing in the change in visual function and on retinal structure at Month 12 and 24. Exploratory objectives: 1. To explore the effects of alternative dosing versus monthly dosing on peripheral visual function at Month 12 and 24 as assessed by contrast sensitivity and reading performance. 2. To explore the effects of alternative dosing versus monthly dosing on lesion growth at Month 12 and 24 as assessed by retinal function measurements quantified with microperimetry at selected study sites. ;Primary end point(s): The primary objective is to demonstrate the non-inferiority of two alternative dosing regimens of ranibizumab versus monthly dosing of ranibizumab as determined by the mean change in best-corrected visual acuity (BCVA) from Baseline to Month 12 as assessed with ETDRS-like VA charts at an initial distance of four meters. This will be achieved by demonstrating that at least one alternative dosing regimen of ranibizumab (0.3 mg or 0.5 mg) is non-inferior to ranibizumab (0.3 mg) administered monthly. | — |
Countries
Belgium, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed