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OpenTrials
Completed

NCT Number: NCT01972763

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

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.

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Key information

Conditions

Recalcitrant Wet Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.

Primary outcomes

  1. Mean change in vision

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Northern California Retina Vitreous Associates

Other

Collaborators

  • Genentech, Inc.

Registry information

Acronym: RESCUE

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2013
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.