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Completed

NCT Number: NCT00764738

Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN 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.

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Key information

Conditions

Neovascular Age Related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Retina Macula Institute

Torrance, California, 90503, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT, Multifocal ERG, Microperimetry

Device

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.

Ranibizumab Ophthalmic

Drug

0.5 mg ranibizumab vs 2.0 mg ranibizumab

Primary outcomes

  1. Multifocal Electroretinography N1-P1 Amplitude

    Time frame: One Year

    As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1).

  2. Microperimetry Mean Sensitivity

    Time frame: One Year

Secondary outcomes

  1. Best Corrected Visual Acuity

    Time frame: One Year

  2. Central Foveal Thickness on Optical Coherence Tomography

    Time frame: One Year

Sponsors and collaborators

Lead sponsor

Retina Macula Institute

Other

Registry information

Official study title

Study Investigating High Resolution OCT, Multifocal ERG and Microperimetry Outcomes of Monthly vs As Needed Ranibizumab in Neovascular Age-Related Macular Degeneration

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 2, 2008
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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