Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab.



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/2/2016
Start Date:July 2011
End Date:September 2012
Contact:Clara J Lee, BS
Email:CJL015@ucsd.edu
Phone:858-246-0440

Use our guide to learn which trials are right for you!

To determine if patients treated early after diagnosis of wet age-related macular
degeneration can return/maintain to their baseline pre-disease BCVA.

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).

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
We found this trial at
4
sites
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Santa Barbara, California 93103
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials