Clinical trial NCT01972763: Ranibizumab for Recalcitrant Wet Age-related Macular Degeneration in Eyes Previously Switched From Bevacizumab and/or Ranibizumab to Aflibercept.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recalcitrant Wet Age-related Macular Degeneration
Lead sponsor: Northern California Retina Vitreous Associates
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2013-10-30
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean change in vision
timeFrame: 6 months
Secondary outcomes:
measure: Mean change in BCVA
timeFrame: 3 months, 9 months, and 12 months
measure: Mean change in SD-OCT central foveal thickness
timeFrame: 3 months, 6 months, 9 months, and 12 months
measure: Percentage of recalcitrant patients that respond by either OCT or VA to Ranibizumab after not having a complete response to previous therapy
timeFrame: 12 months
measure: Percentage of patients that need to be escalated to 1 mg therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
Study officials:
affiliation: Northern California Retina Vitreous Associates
name: Mark R Wieland, MD
role: PRINCIPAL_INVESTIGATOR
References: