Age-Related Macular Degeneration
Conditions
Brief summary
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
Detailed description
Age-related macular degeneration (AMD) is a progressive disease that causes irreversible visual impairment and blindness in nearly 50 million people globally. Although geographic atrophy and neovascularization represent the advanced forms of AMD, neovascular AMD is the more aggressive form and accounts for almost 90% of blindness from this disease. It is characterized by choroidal neovascularization (CNV) which is the development of abnormal blood vessels underneath the retina. Randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with Lucentis (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 Lucentis for the treatment of neovascular AMD (see investigator brochure). This study could provide insight as to the reasons that some patients do not experience vision stabilization with Lucentis, and could possibly help physicians to determine which patients are the best candidates for receiving Lucentis. This is an open-label study of 100 treatment-naïve (study eye only) AMD patients treated on-label with intravitreally administered Lucentis. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Their blood will be genotyped and sequenced for various SNPs on VEGF and HTRA1.
Interventions
DRUGRanibizumab
Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.
Sponsors
Genentech, Inc.
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent and comply with the study assessments for the full duration of the study. * Age \> 50 years. * Treatment naïve (study eye only) AMD patients that are determined to be candidates for ranbizumab. * Visual acuity 20/32 to 20/230.
Exclusion criteria
* Pregnancy * Prior enrollment in the study * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD. * Any other condition that the investigator believes would pose a significant hazard to the subject if on-label ranibizumab were prescribed * Any participation in another simultaneous medical investigation or trial for AMD \*Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Gaining ≥ 0 Letters of Visual Acuity in Response to Ranibizumab Treatment Over a 4 Month Period. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Who Lose Visual Acuity (Gain <0 Letters) at 4, 6 and 12 Months After Initial Treatment. | 5 years |
| To Determine Whether Change in Retinal Thickness is Correlated With Genotype | 5 years |
| To Determine the Mean Number of Injections Per Year Patients in the Study Require. | 5 years |
Countries
United States
Participant flow
Pre-assignment details
The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.
Participants by arm
| Arm | Count |
|---|---|
| Lucentis Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.
Ranibizumab: Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Gaining ≥ 0 Letters of Visual Acuity in Response to Ranibizumab Treatment Over a 4 Month Period.
Time frame: 5 years
Population: The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.
Secondary
To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Who Lose Visual Acuity (Gain <0 Letters) at 4, 6 and 12 Months After Initial Treatment.
Time frame: 5 years
Population: The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.
Secondary
To Determine the Mean Number of Injections Per Year Patients in the Study Require.
Time frame: 5 years
Population: The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.
Secondary
To Determine Whether Change in Retinal Thickness is Correlated With Genotype
Time frame: 5 years
Population: The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.