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Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept. (RESCUE)

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ClinicalTrials.gov Identifier: NCT01972763
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Northern California Retina Vitreous Associates

Tracking Information
First Submitted Date  ICMJE October 24, 2013
First Posted Date  ICMJE October 30, 2013
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
Mean change in vision [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01972763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
  • Mean change in BCVA [ Time Frame: 3 months, 9 months, and 12 months ]
  • Mean change in SD-OCT central foveal thickness [ Time Frame: 3 months, 6 months, 9 months, and 12 months ]
  • 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 ]
  • Percentage of patients that need to be escalated to 1 mg therapy [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept.
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recalcitrant Wet Age-related Macular Degeneration
Intervention  ICMJE Drug: Ranibizumab
Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Drug: Ranibizumab
  • Active Comparator: 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.
    Intervention: Drug: Ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2013)
8
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01972763
Other Study ID Numbers  ICMJE ML28904
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northern California Retina Vitreous Associates
Study Sponsor  ICMJE Northern California Retina Vitreous Associates
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Mark R Wieland, MD Northern California Retina Vitreous Associates
PRS Account Northern California Retina Vitreous Associates
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP