Lucentis in Advanced Macular Degeneration
| Status: | Archived |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2009 |
| End Date: | January 2012 |
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.
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.
We found this trial at
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Stanford university Hospital and Clinics Throughout our history, we have pioneered medical advances that save...
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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