ranibizumab
DrugGroup 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
Other names: Lucentis
NCT Number: NCT00896779
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.
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Notify Me50 year and older
All sexes
Interventional
Phase 2
California Pacific Medical Center, San Francisco, California, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects will be eligible if the following criteria are met:
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from this study:
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
Other names: Lucentis
Time frame: 12 months
Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m ^2 at 8 feet. Number of correctly read letters were reported.
Steven R. Sanislo
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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