Back to resultsRanibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept. (RESCUE)
Primary Purpose
Recalcitrant Wet Age-related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Recalcitrant Wet Age-related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age greater than or equal to 50 years
- Best-corrected ETDRS VA between 20/25 to 20/320
- Total area of subretinal hemorrhage and/or fibrosis comprising less than 50% of lesion
- Any neovascular lesion type of ARMD having previously received at least 3 doses 1.25 mg of bevacizumab and/or ranibizumab (minimum 3 monthly injections) followed by 3 monthly doses of aflibercept 2.0 mg (with last injection being within 8 weeks) with evidence of recalcitrant ARMD, defined by at least one of the following: persistent subretinal fluid with or without intraretinal cystic edema on SD-OCT and/or leakage on fluorescein angiography
Exclusion Criteria:
- Pregnancy (positive pregnancy test) or lactation or pre-menopausal 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
- History of prior vitrectomy surgery
- Previous treatment with photodynamic therapy, radiation, or any other intravitreal drug delivery, such as dexamethasone or triamcinolone
- Subretinal hemorrhage involving the central fovea > 1 disc area, subfoveal atrophy
- CNVM secondary to causes other than ARMD
- Previous retinal pigment epithelial tear
Sites / Locations
- Northern California Retina Vitreous Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ranibizumab 1 mg
Ranibizumab 0.5 mg
Arm Description
Subjects will receive Ranibizumab 0.5 mg for 3 doses and then be separated into 2 arms based on initial response. In this Arm (Arm 1), patients will receive 1 mg of Ranibizumab monthly for the remainder of the study, if persistent or worse subretinal fluid with or without intraretinal cysts on SD-OCT is present.
Subjects will receive Ranibizumab 0.5 mg for 3 doses and then be separated into 2 arms based on initial response. In this Arm (Arm 2), patients will receive 0.5 mg of Ranibizumab monthly for the remainder of the study, if complete resolution of subretinal fluid on SD-OCT is present.
Outcomes
Primary Outcome Measures
Mean change in vision
Secondary Outcome Measures
Mean change in BCVA
Mean change in SD-OCT central foveal thickness
Percentage of recalcitrant patients that respond by either OCT or VA to Ranibizumab after not having a complete response to previous therapy
Percentage of patients that need to be escalated to 1 mg therapy
Full Information
NCT ID
NCT01972763
First Posted
October 24, 2013
Last Updated
February 1, 2019
Sponsor
Northern California Retina Vitreous Associates
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01972763
Brief Title
Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept.
Acronym
RESCUE
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern California Retina Vitreous Associates
Collaborators
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine the effectiveness of Ranibizumab 0.5 mg or 1.0 mg in subjects who were previously treated with Bevacizumab and subsequently switched to Aflibercept. These subjects have demonstrated a sub-optimal therapeutic response to the previous therapies; therefore, the study aims to see if Ranibizumab may have a greater treatment effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recalcitrant Wet Age-related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab 1 mg
Arm Type
Active Comparator
Arm Description
Subjects will receive Ranibizumab 0.5 mg for 3 doses and then be separated into 2 arms based on initial response. In this Arm (Arm 1), patients will receive 1 mg of Ranibizumab monthly for the remainder of the study, if persistent or worse subretinal fluid with or without intraretinal cysts on SD-OCT is present.
Arm Title
Ranibizumab 0.5 mg
Arm Type
Active Comparator
Arm Description
Subjects will receive Ranibizumab 0.5 mg for 3 doses and then be separated into 2 arms based on initial response. In this Arm (Arm 2), patients will receive 0.5 mg of Ranibizumab monthly for the remainder of the study, if complete resolution of subretinal fluid on SD-OCT is present.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.
Primary Outcome Measure Information:
Title
Mean change in vision
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean change in BCVA
Time Frame
3 months, 9 months, and 12 months
Title
Mean change in SD-OCT central foveal thickness
Time Frame
3 months, 6 months, 9 months, and 12 months
Title
Percentage of recalcitrant patients that respond by either OCT or VA to Ranibizumab after not having a complete response to previous therapy
Time Frame
12 months
Title
Percentage of patients that need to be escalated to 1 mg therapy
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age greater than or equal to 50 years
Best-corrected ETDRS VA between 20/25 to 20/320
Total area of subretinal hemorrhage and/or fibrosis comprising less than 50% of lesion
Any neovascular lesion type of ARMD having previously received at least 3 doses 1.25 mg of bevacizumab and/or ranibizumab (minimum 3 monthly injections) followed by 3 monthly doses of aflibercept 2.0 mg (with last injection being within 8 weeks) with evidence of recalcitrant ARMD, defined by at least one of the following: persistent subretinal fluid with or without intraretinal cystic edema on SD-OCT and/or leakage on fluorescein angiography
Exclusion Criteria:
Pregnancy (positive pregnancy test) or lactation or pre-menopausal 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
History of prior vitrectomy surgery
Previous treatment with photodynamic therapy, radiation, or any other intravitreal drug delivery, such as dexamethasone or triamcinolone
Subretinal hemorrhage involving the central fovea > 1 disc area, subfoveal atrophy
CNVM secondary to causes other than ARMD
Previous retinal pigment epithelial tear
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R Wieland, MD
Organizational Affiliation
Northern California Retina Vitreous Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept.
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