Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | October 2008 |
| End Date: | October 2009 |
| Contact: | Lillian Chen |
| Email: | lillian.rmi@gmail.com |
| Phone: | 310-944-9393 |
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.
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
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