NCT02403128

Brief Summary

Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

March 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 14, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

4.7 years

First QC Date

March 23, 2015

Last Update Submit

August 6, 2019

Conditions

Macular EdemaRetinal Artery Macroaneurysm

Keywords

362.17

Outcome Measures

Primary Outcomes (1)

  • Safety profile as demonstrated by the incidence and severity of ocular and systemic adverse events in patients with macular edema caused by retina artery macroaneurysm(s) after intravitreal injection of 2 mg of aflibercept

    six months

Secondary Outcomes (5)

  • Change in best-corrected ETDRS visual acuity at 3 and 6 months.

    six months.

  • Change in central field macular thickness at 3 and 6 months

    six months

  • Proportion of eyes completely dry by spectral domain OCT

    six months

  • Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography

    six months

  • Number of patients requiring additional treatment beyond baseline and total number of treatments

    six months

Study Arms (1)

Patients with macular edema from RAM

EXPERIMENTAL

Intravitreal aflibercept 2.0 mg injection for eyes meeting eligibility criteria will be administered at baseline. Reinjection of the drug for protocol-defined criteria at least two months after previous injection.

Drug: aflibercept

Interventions

afliberceptDRUG

Intravitreal injection of 2.0 mg aflibercept at baseline, and repeated no sooner than two months from the previous injection for persistent macular edema as defined in the protocol.

Also known as: Eylea
Patients with macular edema from RAM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic macular edema caused by RAM in one of the eyes. If both eyes are involved, the eye with worse central foveal thickness will be enrolled in the study.
  • CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea
  • Best-corrected visual acuity of 73 to 24 letters.
  • Willing and able to comply with clinic visits and study-related procedures.
  • Willing to provide informed consent -

You may not qualify if:

  • Media opacity
  • pre-retinal fibrosis, retinal detachment, vitreo-macular traction
  • Infectious keratitis, conjunctivitis, blepharitis or scleritis
  • Any ocular surgery during the preceding 3 months.
  • aphakia or uncontrolled glaucoma
  • subfoveal hemorrhage
  • History of systemic or intravitreal anti-VEGF injections, intravitreal steroid injection or implant, or laser treatment to RAM within six months
  • Any other ocular disease responsible for decrease in vision.
  • Concomitant ocular disease that can cause increase in foveal thickness
  • Ocular inflammation from any cause
  • Recent (\<3 months) history of a thromboembolic event
  • Pregnant or breast feeding women.
  • Sexually active men or women of child bearing potential who are unwilling to practice adequate contraception during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois Retina and Eye Associates

Peoria, Illinois, 61615, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Kamal Kishore, MD

    Illinois Retina and Eye Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 31, 2015

Study Start

May 14, 2015

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations

US(1)