Patients with subfoveal choroidal neovascularization associated with Age-Related Macular Degeneration MedDRA version: 9.1 Level: LLT Classification code 10064930 Term: Age-related macular degeneration
Conditions
Interventions
Product Name: Bevasiranib Sodium
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bevasiranib Sodium
Other descriptive name: Bevasiranib Sodium
Concentration unit: mg/ml milligram(s)/m
Sponsors
Opko Health, Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have predominantly classic, minimally classic, or occult with no classic lesions, secondary to AMD, with a total lesion size (including blood, scarring and neovascularization) of = 12 total disc areas (30.48 mm2); 2. Patients must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye; 3. Occult with no classic lesions must have evidence of presumed recent disease progression defined as: a. The presence of subretinal hemorrhage OR b. Loss of > 1 line of VA during the past 12 weeks OR c. FA documented lesion growth by = 10% during the past 12 weeks; 4. Patients must be age 50 or older; 5. Patient must sign and retain a copy of the written informed consent form; 6. Patients must be willing and able to return for scheduled follow-up examinations for two years; and 7. Women must be post-menopausal = 1 year, or surgically sterilized. If not, a negative serum pregnancy test is required within 14 days of randomization. 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: 1. Patients who have been previously treated for AMD in the study eye with any agent except vitamins and/or minerals; 2. Patients with concomitant disease in the study eye, including uveitis, presence of pigment epithelial tears or rips, acute ocular or periocular infection; 3. Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22mmHg in the study eye despite adequate treatment with medication; 4. Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye; 5. Patients with any subfoveal scarring, atrophy, or hemorrhage > 500µm in the study eye; 6. Patients whose CNV lesion in the study eye contains more than 25% scarring and/or fibrosis; 7. Patients with inadequate pupillary dilation or significant media opacities in the study eye, which may interfere with visual acuity or the evaluation of the posterior segment, including cataract, which is likely to require surgical intervention within the 100 week active study period; 8. Patients who present with choroidal neovascularlization due to causes other than AMD, including ocular Histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or high myopia (spherical equivalent = 8 Diopters or axial length = 25mm); 9. Patients who have undergone any intraocular surgery of the study eye within 12 weeks prior to the screening visit; 10. Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit; 11. Patients with previous posterior vitrectomy of the study eye; 12. Patients with known serious allergies to fluorescein dye, not amenable to treatment with diphenhydramine; 13. Patients who underwent previous radiation therapy to the head or neck in the region of the study eye; 14. Patients who received treatment with any investigational drug within 4 weeks prior to the screening visit; 15. Patients with an intravitreal device or drug implant in the study eye; 16. Patients with a recent history of acute coronary syndrome, coronary angioplasty, aorto-coronary bypass, or stroke. 17. Patients with any other condition, which in the judgment of the investigator would prevent the patient from completing the study; 18. Premenopausal women not using adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this Phase 3, multi-center, randomized, double-masked, controlled, study is to show that after initial VEGF antagonist therapy with 3 doses of Lucentis®, maintenance therapy with bevasiranib (2.5 mg) administered at two dosing regimens (8 weeks apart and 12 weeks apart) is not inferior to continued treatment with Lucentis® every 4 weeks with regard to safety and efficacy. o Efficacy endpoints: - Primary efficacy measure: The proportion of subjects at 60 weeks in each group with a successful visual acuity outcome. o Safety endpoints: - The incidence of injection-related complications. - Frequency of severe loss of visual acuity (6 or more lines) from baseline to week 60. - Rate of serious ocular adverse events. - Incidence of increased intraocular pressure requiring medical or surgical intervention. - All adverse events reported, whether deemed related to treatment or not. ;Secondary Objective: o Secondary efficacy measure: - The proportion of subjects who have a successful visual acuity outcome at 60 weeks and had no need for rescue therapy in the first year after treatment. - Time from treatment initiation to first use of rescue therapy. - Mean visual acuity change (in VA letters) from baseline at 60 weeks, and at each visit. ;Primary end point(s): Safety Endpoints: Ocular safety will be evaluated by assessing: · Incidence of adverse events/serious adverse events · Visual acuity · Ophthalmic examination · Intraocular pressure · Fundus findings Efficacy Endpoints Primary efficacy measure: . The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision). Secondary efficacy measures: . The proportion of patients who have a successful visual acuity outcome at week 60 and had no need for rescue therapy with Lucentis®. . Time from treatment initiation to first use of rescue therapy. . The distribution of change in visual acuity from | — |
Countries
Austria, Italy, Portugal, Spain
Outcome results
None listed