Male and female patients > 50 years of age with subfoveal choroidal neovascularization (CNV) secondary to AMD. MedDRA version: 7.0 Level: LLT Classification code 10060837
Conditions
Interventions
Product Name: Lucentis
Product Code: RFB002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ranibizumab
CAS Number: 347396-82-1
Current Sponsor code: RFB002
Other descriptive name: rh
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients 50 years of age or greater • Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component • CNV lesion in the study eye is =5400 microns in greatest linear dimension • Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320) • Willing to return for scheduled visits for 4 month period • Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study 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
Exclusion criteria: • Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes • Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy • Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Day 1 • Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as “low dose” up to 100 mg qd for prophylaxis of MI and/or stroke is permitted during study • Current use or of likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambuto is excluded • History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (, uveitis, cyclitis etc.) • History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma mediation). • History of submacular surgery or other surgical intervention for AMD in the study eye within two months preceding Day 1 • 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 • Spherical equivalent of the refractive error in the study eye demonstrating more than –8 diopters of myopia • Presence of a retinal pigment epithelial tear involving the macula in the study eye • Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia • Active intraocular inflammation (grade trace or above) in the study eye • Any active infection involving eyeball adnexa • Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of RFB002 (ranibizumab). Safety of the combined treatments will be assessed with visual acuity measurements and ophthalmic examinations, as well as an evaluation of adverse events and vital signs. The primary variable for this assessment is the incidence of severe vision loss, i.e. the number of patients who lose >30 letters in best corrected visual acuity (BCVA) from baseline, beginning within 14 days of the combination treatment and persisting for longer than 14 days. ;Secondary Objective: The secondary variable is the incidence of moderate vision loss, i.e. the number of patients who lose >15 letters in BCVA from baseline, beginning within 14 days of the combination treatment and persisting for longer than 14 days.;Primary end point(s): Safety of the combined treatments will be assessed with visual acuity measurements and ophthalmic examinations, as well as an evaluation of adverse events and vital signs. The primary variable for this assessment is the incidence of severe vision loss, i.e. the number of patients who lose >30 letters in best corrected visual acuity (BCVA) from baseline, beginning within 14 days of the combination treatment and persisting for longer than 14 days. | — |
Countries
Austria
Outcome results
None listed