Intravitreal Injections of rhuFab V2 in Combination With Visudyne in Subjects With Age Related Macular Degeneration (AMD)

Genentech

Status and phase

Completed

Phase 2

Phase 1

Conditions

Age-Related Maculopathy

Treatments

Drug: rhuFab V2 (ranibizumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00056823

FVF2428g

Details and patient eligibility

About

The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular degeneration.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed informed consent and authorization of use and disclosure of protected health information
Age >=50 years
Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne(R) product labeling
Treatment with verteporfin anticipated or expected
Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to AMD in the study eye
A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is >=50% of the total lesion area
Total lesion size >=5400 um in greatest linear dimension (GLD)
Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye

Exclusion criteria

Treatment with verteporfin in the study eye less than 3 months preceding Day 0
Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
More than three prior treatments with verteporfin PDT in the study eye within 12 months preceding Day 0
Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in the study eye
Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, rhuFab V2, anecortave acetate, protein kinase C inhibitors, etc.) Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
Previous subfoveal focal laser photocoagulation in the study eye
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals studies)
Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 disc area in size
Subfoveal fibrosis or atrophy in the study eye
Clinical or angiographic evidence of retinal angiomatous proliferation in the study eye, if there is also no angiographic evidence of classic CNV
CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Retinal pigment epithelium tear involving the macula in the study eye
Any concurrent intraocular condition (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, either could require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period
Active intraocular inflammation (grade trace or above) in the study eye
Current vitreous hemorrhage in the study eye
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
History of idiopathic or autoimmune-associated uveitis in either eye. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Aphakia or absence of the posterior capsule in the study eye
Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
Intraocular surgery (including cataract surgery) on the study eye within 1 month preceding Day 0
Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with anti-glaucoma medication)
Premenopausal women not using adequate contraception
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 from treatment complications.
Current treatment for active systemic infection
Contraindications to verteporfin photodynamic therapy (as determined by the investigator)
History of allergy to fluorescein, not amenable to treatment
Inability to dilate pupils to >=6 mm in diameter
Inability to comply with study or follow up procedures