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

Age-Related Macular Degeneration Clinical Trial

— COMPASS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01402544
• Other study ID #: 110567
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• ranibizumab
0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.

Locations

Country	Name	City	State
United States	California Retina Consultants	Bakersfield	California
United States	Shiley Eye Center, UCSD	La Jolla	California
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	California Retina Consultants	Santa Barbara	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months	PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.	Baseline, Month 6 and Month 12
Secondary	Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.	Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost.	Baseline, Month 6 and Month 12
Secondary	Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months		Baseline, Month 6 and Month 12