View Clinical Trial (Medical Research Study)
Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab.
| City: |
|
La Jolla |
| State: |
|
California |
| Zip Code: |
|
92093 |
| Conditions: |
|
Age-Related Macular Degeneration |
| Purpose: |
|
To determine if patients treated early after diagnosis of wet age-related macular
degeneration can return/maintain to their baseline pre-disease BCVA.
|
| Study Summary: |
|
We will conduct an open label, multi-center study of naïve AMD patients that are identified
early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry)
to assess if treating with ranibizumab monthly can restore all patients to their baseline
vision pre-AMD. Recent randomized clinical trials (MARINA, ANCHOR) have conclusively
demonstrated that continued intravitreal therapy with ranibizumab in patients with subfoveal
CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in
vision in at least a third of the patients and has led to the approval of ranibizumab (0.5
mg) for the treatment of neovascular AMD.
Patients will receive monthly intravitreal ranibizumab injections for 12 months (with dose
holding for return to baseline/ 20/20 or better and no evidence of fluid on SD-OCT or FA).
All patients will have ETDRS vision and SD-OCT, and complete exam at each monthly visit.
Patients will each have a blood analysis for genetics (either during the GALLEY study in
which they converted to wet AMD and entered COMPASS or during this study).
|
| Criteria: |
|
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study
- Age > 50 years
- Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3
months of disease onset for all others
- Patients that have lost > 5 letters from baseline best vision
- BCVA 20/25-20/320
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered
effective means of contraception: surgical sterilization or use of oral
contraceptives, barrier contraception with either a condom or diaphragm in
conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial which includes
an intervention (Patients could be participating in a non-interventional study such
as the GALLEY study)
- Juxtafoveal and extrafoveal wet-AMD
|
| NCT ID: |
|
NCT01402544 |
| Primary Contact: |
|
Principal Investigator
Kang Zhang, MD, PhD
University of California, San Diego
Clara J Lee, BS
Phone: 858-246-0440
Email: CJL015@ucsd.edu
|
| Backup Contact: |
|
Email: dmm003@ucsd.edu
Della M Morales, BS
Phone: 858-246-0270
|
| Location Contact: |
|
La Jolla, California 92093
United States
Clara J Lee, BS
Phone: 858-246-0440
Email: cjl015@ucsd.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|