Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept.
NCT ID: NCT01972763
Last Updated: 2019-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2013-10-31
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ranibizumab 1 mg
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.
Ranibizumab
Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.
Ranibizumab 0.5 mg
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.
Ranibizumab
Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.
Interventions
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Ranibizumab
Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Northern California Retina Vitreous Associates
OTHER
Responsible Party
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Principal Investigators
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Mark R Wieland, MD
Role: PRINCIPAL_INVESTIGATOR
Northern California Retina Vitreous Associates
Locations
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Northern California Retina Vitreous Associates
Mountain View, California, United States
Countries
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Other Identifiers
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ML28904
Identifier Type: -
Identifier Source: org_study_id
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