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

Conditions

• Recalcitrant Wet Age-related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Oct 30, 2013

Start date

Oct 31, 2013

Status verified

Feb 2019

Primary completion

Jul 31, 2018

Completion

Jul 31, 2018

Study Design

Enrollment

12 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Mean change in vision [ Time Frame: 6 months ]

Locations (1)

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