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
  Purpose

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.


Condition Intervention Phase
Neovascular Age Related Macular Degeneration
Device: OCT, Multifocal ERG, Microperimetry
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Investigating High Resolution OCT, Multifocal ERG and Microperimetry Outcomes of Monthly vs As Needed Ranibizumab in Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Retina Macula Institute:

Primary Outcome Measures:
  • Photoreceptor preservation for Monthly and PRN therapy and visual acuity change. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Monthly
Ranibizumab injections every month for 12 months.
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: As Needed
Ranibizumab injections monthly for 4 months then as needed thereafter.
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.


  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764738

Locations
United States, California
Retina Macula Institute
Torrance, California, United States, 90503
Sponsors and Collaborators
Retina Macula Institute
Investigators
Principal Investigator: Ron P. Gallemore, MD, PhD Retina Macula Institute
  More Information

No publications provided

Responsible Party: Ron P. Gallemore, Retina Macula Institute
ClinicalTrials.gov Identifier: NCT00764738     History of Changes
Other Study ID Numbers: FVF4495s
Study First Received: September 30, 2008
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Macula Institute:
ARMD
AMD
exudative AMD

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014