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CompletedNCT01473251Updated Dec 17, 2014

Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration

An interventional study of Avastin and Avastin in Exudative Macular Degeneration and Diabetic Macular Edema, sponsored by Vitreo-Retinal Associates, Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-12-17.

Sponsored by Vitreo-Retinal Associates, Michigan · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.

02

Conditions studied

  • Exudative Macular Degeneration
  • Diabetic Macular Edema
03

In context

Wet Macular Degeneration

233 studies on the registry are indexed under Wet Macular Degeneration; 19 are open to participants now.

This study's enrollment of 16 is below the median of 56 across 182 interventional studies indexed under Wet Macular Degeneration.

Browse Wet Macular Degeneration studies →

Lead sponsor

Vitreo-Retinal Associates, Michigan is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
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

  • Male or female age 18 to 85 with diabetes and hemoglobin A1C \</= 10, or exudative macular degeneration.
  • Diabetic macular edema with average retinal thickness central subfield >/= 290um.

Exclusion criteria

Exclusion Criteria:

  • Macular atrophy/fibrosis.
  • Ocular anti-VEGF treatment within 3 months.
  • Treatment with topical or oral carbonic-anhydrase inhibitor within one month
  • Laser photocoagulation within 3 months (diabetic cohort)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Avastin for Diabetic Macular Edema

    1.25 mg avastin monthly for 4 months

    Drug: Avastin

  • Active comparator
    Avastin for Exudative Macular Degeneration

    1.25 mg Avastin monthly for 4 months

    Drug: Avastin

  • Active comparator
    Lucentis for Exudative Macular Degeneration

    0.5 mg Lucentis monthly for 4 months

    Drug: Lucentis

Interventions

  • 1.25 mg monthly for 4 months

  • 1.25 mg monthly for 4 months

  • 0.5 mg monthly for 4 months

06

What researchers measure

Primary outcomes

  1. Analysis of collected vitreous samples to identify biomarkers.

    Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema.

    Time frame: End of study

07

Study locations

1 site
  • Vitreo-Retinal Associates
    Grand Rapids, Michigan 49525, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01473251
Lead sponsor
Vitreo-Retinal Associates, Michigan
Collaborators
Van Andel Research Institute
Responsible party
Sponsor
First posted
Nov 17, 2011
Start date
Nov 2011
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Dec 17, 2014

Study contacts

Louis C. Glazer, MD
principal investigator · Vitreo Retinal Associates

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Bevacizumab · Ranibizumab

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