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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recalcitrant Wet Age-related Macular Degeneration Drug: Ranibizumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : October 2013
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Ranibizumab
Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.
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.
 Drug: Ranibizumab
Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in vision [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mean change in BCVA [ Time Frame: 3 months, 9 months, and 12 months ]
  2. Mean change in SD-OCT central foveal thickness [ Time Frame: 3 months, 6 months, 9 months, and 12 months ]
  3. 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 ]
  4. Percentage of patients that need to be escalated to 1 mg therapy [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972763


Locations
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United States, California
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Sponsors and Collaborators
Northern California Retina Vitreous Associates
Genentech, Inc.
Investigators
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Principal Investigator: Mark R Wieland, MD Northern California Retina Vitreous Associates
More Information
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Responsible Party: Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier: NCT01972763    
Other Study ID Numbers: ML28904
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents