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Status unknownNCT02403128Updated Aug 8, 2019

Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms

A Phase 1 interventional study of aflibercept in Macular Edema and Retinal Artery Macroaneurysm, sponsored by Kamal Kishore, MD. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by Kamal Kishore, MD · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Baseline evaluation will consist of measurement of best-corrected ETDRS visual acuity, complete eye exam, including IOP measurement, color photos and intravenous fluorescein angiography, spectral domain OCT and vitals. Patients meeting eligibility criteria will be treated with an intravitreal injection of 2.0 mg aflibercept under usual aseptic precautions. Follow up visits will be on Day 7, 30, 60, 90, 120, 150 and 180. At each follow-up visit, best-corrected ETDRS visual acuity, IOP measurement and central foveal thickness (CFT) by SDOCT will be obtained. Color photos and IVFA will be performed at month 3 and 6 visits.

Retreatment shall be performed no sooner than two months after previous injection for one or more the following criteria 1. CFT >310 microns 2. Intraretinal or subretinal fluid on SDOCT 3. Increase in CFT by 50 or more microns from the lowest value observed after intravitreal aflibercept injection 4. Decrease in vision by 5 or more letters frpm the previous visit associated with OCT evidence of macular edema. 5. Appearance of new hemorrhage on color photographs.

Final follow-up will be at six months. Data collected will include, change in ETDRS visual acuity from the baseline, change in CFT, number of injections, number of eyes completely dry by SDOCT, and number of eyes with a thrombosed RAM by IVFA.

02

Conditions studied

  • Macular Edema
  • Retinal Artery Macroaneurysm

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Keywords

  • 362.17
03

In context

Macular Edema

848 studies on the registry are indexed under Macular Edema; 57 are open to participants now.

This study's enrollment of 6 is below the median of 50 across 624 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

This is the only study on the registry with Kamal Kishore, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea
  3. Best-corrected visual acuity of 73 to 24 letters.
  4. Willing and able to comply with clinic visits and study-related procedures.
  5. Willing to provide informed consent -

Exclusion criteria

Exclusion Criteria:

  1. Media opacity
  2. pre-retinal fibrosis, retinal detachment, vitreo-macular traction
  3. Infectious keratitis, conjunctivitis, blepharitis or scleritis
  4. Any ocular surgery during the preceding 3 months.
  5. aphakia or uncontrolled glaucoma
  6. subfoveal hemorrhage
  7. History of systemic or intravitreal anti-VEGF injections, intravitreal steroid injection or implant, or laser treatment to RAM within six months
  8. Any other ocular disease responsible for decrease in vision.
  9. Concomitant ocular disease that can cause increase in foveal thickness
  10. Ocular inflammation from any cause
  11. Recent (\<3 months) history of a thromboembolic event
  12. Pregnant or breast feeding women.
  13. Sexually active men or women of child bearing potential who are unwilling to practice adequate contraception during the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Patients with macular edema from RAM

    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

  • Drugaflibercept

    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

06

What researchers measure

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

    Time frame: six months

Secondary outcomes

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

    Time frame: six months.

  2. Change in central field macular thickness at 3 and 6 months

    Time frame: six months

  3. Proportion of eyes completely dry by spectral domain OCT

    Time frame: six months

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

    Time frame: six months

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

    Time frame: six months

07

Study locations

1 site
  • Illinois Retina and Eye Associates
    Peoria, Illinois 61615, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2015 (actual). Primary completion is estimated for Feb 2020, 57 months after the start.

Of 26 phase 1 interventional studies under Macular Edema, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 57 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2015
First posted
Mar 31, 2015
StartActual
May 14, 2015
Primary completionEst.
Feb 2020
CompletionEst.
Feb 2020
Last update
Aug 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02403128
Lead sponsor
Kamal Kishore, MD
Responsible party
Kamal Kishore, MD (Principal Investigator, Illinois Retina and Eye Associates) — Sponsor-investigator
First posted
Mar 31, 2015
Start date
May 14, 2015
Primary completion
Feb 2020 (estimated)
Completion
Feb 2020 (estimated)
Last update
Aug 8, 2019

Study contacts

Kamal Kishore, MD
principal investigator · Illinois Retina and Eye Associates

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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