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Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
Retina Macula Institute
ClinicalTrials.gov Identifier:
NCT00764738
First received: September 30, 2008
Last updated: March 18, 2013
Last verified: March 2013
History of Changes

September 30, 2008
March 18, 2013
October 2008
November 2011   (final data collection date for primary outcome measure)
Photoreceptor preservation for Monthly and PRN therapy and visual acuity change. [ Time Frame: One Year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764738 on ClinicalTrials.gov Archive Site
Not Provided
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Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
Study Investigating High Resolution OCT, Multifocal ERG and Microperimetry Outcomes of Monthly vs As Needed Ranibizumab in Neovascular Age-Related Macular Degeneration

Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neovascular Age Related Macular Degeneration
Device: OCT, Multifocal ERG, Microperimetry

OCT performed monthly. Fluorescein Angiography performed at baseline, month 3, month 5, month 8 and month 12.

Microperimetry performed at baseline, month 3, month 5, month 8, and month 12 for monthly ranibizumab and at baseline, month 3, month 5 through month 12 for as needed ranibizumab.

Multifocal ERG done at the same monthly visits as the microperimetry.
  • Active Comparator: Monthly
    Ranibizumab injections every month for 12 months.
    Intervention: Device: OCT, Multifocal ERG, Microperimetry
  • Active Comparator: As Needed
    Ranibizumab injections monthly for 4 months then as needed thereafter.
    Intervention: Device: OCT, Multifocal ERG, Microperimetry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age greater or equal to 50 years old.
  • Patients with active neovascular AMD

Exclusion Criteria:

  • Pregnancy (Positive pregnancy test) or lactation.
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
  • Previous PDT therapy
  • Previous intravitreal steroid therapy within last 3 months
  • Previous anti-VEGF therapy in the past month
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00764738
FVF4495s
Yes
Ron P. Gallemore, Retina Macula Institute
Retina Macula Institute
Not Provided
Principal Investigator: Ron P. Gallemore, MD, PhD Retina Macula Institute
Retina Macula Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP