Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT00656903
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2008-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-related Macular Degeneration
Sponsor:
National Eye Institute (NEI)
Organization:
Study Overview
Official Title:
High Speed Indocyanine Green Angiography Findings in Induction/PRN Regimen of Intravitreal Ranibizumab Injection for Neovascular Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2014-08-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will use an eye imaging test called high speed indocyanine green angiography (HS-ICG), which examines leaky vessels in the eye, to try to find out why individuals respond differently to ranibizumab (Lucentis) treatment for wet age-related macular degeneration (AMD). The drug was recently approved by the Food and Drug Administration to treat this disease, but the response to the treatment varies markedly among individuals.
People 50 years of age and older with wet AMD and vision that meets the research protocol criteria may be eligible for this study. Participants undergo the following procedures:
Ranibizumab injections in the study eye once a month for 4 months. Additional injections are given only if the study eye shows signs of bleeding or leaking fluid. The eye is numbed before the injection and the eye area is cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection to prevent infection.
Clinic visits once a month for 2 years for evaluations to monitor the response to treatment. The evaluations may include the following examinations and tests:
* Eye examination with dilation, optical coherence tomography and photography: The examination measures visual acuity, thickness of your retina (the back of the eye) andeye pressure. Bright lights will also be used so that the doctor can see the back of your eye. Photographs of the eye may be taken.
* Fluorescein angiography to examine the blood vessels in the eye: A dye called fluorescein is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels. This test is done eight times during the study.
* Indocyanine green angiography to examine the blood vessels in the eye: The procedure is the same as for fluorescein angiography, but it uses a dye called indocyanine green. This test is done once a month for the first year of the study and then every 3 months.
People 50 years of age and older with wet AMD and vision that meets the research protocol criteria may be eligible for this study. Participants undergo the following procedures:
Ranibizumab injections in the study eye once a month for 4 months. Additional injections are given only if the study eye shows signs of bleeding or leaking fluid. The eye is numbed before the injection and the eye area is cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection to prevent infection.
Clinic visits once a month for 2 years for evaluations to monitor the response to treatment. The evaluations may include the following examinations and tests:
* Eye examination with dilation, optical coherence tomography and photography: The examination measures visual acuity, thickness of your retina (the back of the eye) andeye pressure. Bright lights will also be used so that the doctor can see the back of your eye. Photographs of the eye may be taken.
* Fluorescein angiography to examine the blood vessels in the eye: A dye called fluorescein is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels. This test is done eight times during the study.
* Indocyanine green angiography to examine the blood vessels in the eye: The procedure is the same as for fluorescein angiography, but it uses a dye called indocyanine green. This test is done once a month for the first year of the study and then every 3 months.
Detailed Description:
Neovascular age-related macular degeneration (AMD) is the leading cause of blindness among elderly in the United States.1 Ranibizumab, an inhibitor of all forms of vascular endothelial growth factor (VEGF), is the first FDA-approved treatment for AMD that significantly improves vision in a quarter to a third of patients and maintains or improves vision in greater than 90% of patients. Ranibizumab decreases the vasopermeability as measured by decreased leakage and fluid on fluorescein (FA) and optical coherence tomography. However, the effect of ranibizumab on the structure and hemodynamics of the choroidal neovascularization (CNV) in AMD, as measured with high-speed indocyanine green angiography (HS-ICG), is not known. The effect or lack of effect on the physical structure of the CNV may help explain the variability of injection frequencies and visual responses among different patients. Since anti-VEGF therapy is designed to inhibit exudative CNV, it is clinically important to develop a standard reproducible method to assess HS-ICG.
In this observational study, our primary objective is to assess whether induction/pro re nata (Induction/PRN) 0.5 mg intravitreal ranibizumab-based treatment for neovascular AMD decreases the size and pattern of the CNV as measured on HS-ICG, as opposed to simply decreasing leakage and fluid as seen on FA and OCT. Although combination therapy is likely the standard treatment for AMD in the future, participants will not be allowed to receive other AMD experimental agents (e.g., immunosuppressive drugs) for either the study or fellow eye while on this study. In consultation with various reading centers, we will attempt to develop a reproducible schema for evaluation of HS-ICG by reviewing pre-treatment and post-treatment HS-ICGs. The grading system development is a secondary objective to achieve a better understanding of anatomical and functional results and an important task for future research. In this study, the first 10 cases will be used to attempt to develop a reproducible grading system. The NEI retina group will review these ICGs and attempt to identify gradable aspects of the lesions that are consistently present on the ICGs. During this time we will continue to collect additional cases for evaluation. The grading system proposed from the first 10 cases will be implemented in the next 10 cases. There will be two independent gradings for each ICG. The results of this dual grading will then be reviewed and problematic areas of grading will be identified. The grading system will be modified based on this experience and reproducibility of the modified grading system will be assessed by re-grading the images in a masked fashion. The modified grading system will be utilized in the next 10 cases. This iterative process will be continued until we have either developed a reproducible and useful grading system or completed the full participant analysis. Another important secondary objective is to examine whether an increased dose of 1 mg of intravitreal ranibizumab-based treatment (administered as 1 mg monthly or 0.5 mg bi-monthly) will decrease leakage and fluid as seen on FA and OCT and/or decrease the size and pattern of CNV on HS-ICG for participants not becoming fluid-free on the standard dose.
In this observational study, our primary objective is to assess whether induction/pro re nata (Induction/PRN) 0.5 mg intravitreal ranibizumab-based treatment for neovascular AMD decreases the size and pattern of the CNV as measured on HS-ICG, as opposed to simply decreasing leakage and fluid as seen on FA and OCT. Although combination therapy is likely the standard treatment for AMD in the future, participants will not be allowed to receive other AMD experimental agents (e.g., immunosuppressive drugs) for either the study or fellow eye while on this study. In consultation with various reading centers, we will attempt to develop a reproducible schema for evaluation of HS-ICG by reviewing pre-treatment and post-treatment HS-ICGs. The grading system development is a secondary objective to achieve a better understanding of anatomical and functional results and an important task for future research. In this study, the first 10 cases will be used to attempt to develop a reproducible grading system. The NEI retina group will review these ICGs and attempt to identify gradable aspects of the lesions that are consistently present on the ICGs. During this time we will continue to collect additional cases for evaluation. The grading system proposed from the first 10 cases will be implemented in the next 10 cases. There will be two independent gradings for each ICG. The results of this dual grading will then be reviewed and problematic areas of grading will be identified. The grading system will be modified based on this experience and reproducibility of the modified grading system will be assessed by re-grading the images in a masked fashion. The modified grading system will be utilized in the next 10 cases. This iterative process will be continued until we have either developed a reproducible and useful grading system or completed the full participant analysis. Another important secondary objective is to examine whether an increased dose of 1 mg of intravitreal ranibizumab-based treatment (administered as 1 mg monthly or 0.5 mg bi-monthly) will decrease leakage and fluid as seen on FA and OCT and/or decrease the size and pattern of CNV on HS-ICG for participants not becoming fluid-free on the standard dose.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 08-EI-0103 | None | None | View |