NCT03071055

Brief Summary

This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2019

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

February 24, 2017

Last Update Submit

October 19, 2020

Conditions

Exudative Age Related Macular Degeneration

Keywords

Macular DegenerationAMDWet AMDLucentis

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is mean change in ETDRS BCVA visual acuity

    The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.

    24 weeks

Secondary Outcomes (6)

  • Proportion of eyes that gain or lose >0 letters at 24 weeks

    24 weeks

  • Proportion of eyes that gain or lose > 5 letters at 24 weeks

    24 weeks

  • Proportion of eyes that gain or lose > 10 letters at 24 weeks

    24 weeks

  • Proportion of eyes that gain or lose > 15 letters at 24 weeks

    24 weeks

  • To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting

    24 weeks

  • +1 more secondary outcomes

Study Arms (2)

ranibizumab

ACTIVE COMPARATOR

ranibizumab 0.5mg in commercially available vial

Drug: Ranibizumab Injection [Lucentis]

ranibizumab pre filled-syringe

EXPERIMENTAL

ranibizumab 0.5mg in soon to be available pre-filled syringe

Drug: Ranibizumab Injection [Lucentis]

Interventions

Ranibizumab Injection [Lucentis]DRUG

intravitreal injection

Also known as: Lucentis
ranibizumabranibizumab pre filled-syringe

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 50 years
  • Exudative age related macular degeneration in study eye involving the fovea
  • Best Corrected Visual Acuity (by ETDRS) letter score in study eye of \< 85 and \> 24 (approximate Snellen equivalent 20/20 to 20/320)
  • Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye
  • At least 30 days from last intravitreal anti-VEGF injection in the study eye

You may not qualify if:

  • Patient who are receiving systemic anti-VEGF or proangiogenic therapy
  • Patients on chronic high doses corticosteroid therapy (\> than 10 mg of oral prednisone or equivalent greater than 10 days)
  • Patients on chronic immunosuppressant therapy
  • Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine
  • History of intravitreal corticosteroids in study eye within 4 months of baseline
  • Uncontrolled hypertension (defined as systolic \>180 mm Hg and/or diastolic \> 100 mm Hg while patient is sitting)
  • History of stroke or APTC event in the previous year
  • Any intraocular surgery in study eye within 90 days of baseline
  • Presence of vitreomacular traction in study eye
  • Presence of significant epiretinal proliferation in study eye
  • Evidence of active infection in either eye
  • Uncontrolled glaucoma in the study eye defined as a pressure \> 25 mmHg on maximal medical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charlotte Eye Ear Nose and Throat Associates, PA

Charlotte, North Carolina, 28210, United States

Location

Charlotte Eye Ear Nose and Throat Associates, PA

Statesville, North Carolina, 28677, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 6, 2017

Study Start

October 1, 2017

Primary Completion

June 3, 2019

Study Completion

June 3, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)