Clinical trial NCT00764738: Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
Official title: Study Investigating High Resolution OCT, Multifocal ERG and Microperimetry Outcomes of Monthly vs As Needed Ranibizumab in Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neovascular Age Related Macular Degeneration
Keywords: ARMD
AMD
exudative AMD
Lead sponsor: Retina Macula Institute
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 91
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Multifocal Electroretinography N1-P1 Amplitude
timeFrame: One Year
measure: Microperimetry Mean Sensitivity
timeFrame: One Year
Secondary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: One Year
measure: Central Foveal Thickness on Optical Coherence Tomography
timeFrame: One Year
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Retina Macula Institute
state: California
Study officials:
affiliation: Retina Macula Institute
name: Ron P. Gallemore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: