NCT00896779

Lucentis in Advanced Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Steven R. Sanislo · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections. Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails". Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy. Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Detailed description

The duration of the study is up to 13 months. This includes up to 30 days during which tests will be performed before treatment. Only one eye will be chosen for the study. Patients can receive up to 12 injections of ranibizumab during this study (the first dose\[s\], plus additional doses \[re treatment as often as every 22 days\] if the doctor determines that additional doses are required). In addition to study drug injections. Several eye examinations and procedures will be performed to evaluate response to treatment. These include: visual acuity testing (eye chart), contrast sensitivity testing, reading speed testing, measurement of time to complete typical daily activities, measurement of the thickness of the central retina, measurement of your central visual field. On the screening visit and two more times during the study fluorescein angiography will be performed. The screening tests included the following: * A review of your medical history * A review of any medications you are or have been taking * Eye examinations, including visual acuity testing (reading letters on an eye chart) * Blood pressure measurement Woman of childbearing potential must also take a urine pregnancy test during the screening period to rule out pregnancy. Upon completion of the study at Month 12 and if it were to occur; early termination visit, the following procedures will be performed: vision exam,OCT,microperimetry,FA/Photos,VFQ,reading performance, contrast sensitivity and TIADL.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	ranibizumab	Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2009-05-12
• Last updated: 2015-06-29
• Results posted: 2015-05-27

Locations

2 sites across 1 country: United States