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

Sponsored by:	Retina Macula Institute
Information provided by:	Retina Macula Institute
ClinicalTrials.gov Identifier:	NCT00764738

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 II Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab Fluorescein D&C Yellow no. 8 BaseLine

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	45
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Monthly: Active Comparator 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.
As Needed: Active Comparator 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.

Arms

Assigned Interventions

Monthly: Active Comparator

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.

As Needed: Active Comparator

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

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

Contacts

Contact: Lillian Chen

310-944-9393

lillian.rmi@gmail.com

Locations

United States, California
Retina Macula Institute	Recruiting
Torrance, California, United States, 90503
Contact: Lillian Chen 310-944-9393 lillian.rmi@gmail.com
Principal Investigator: Ron P. Gallemore, MD, PhD

Sponsors and Collaborators

Retina Macula Institute

Investigators

Principal Investigator:

Ron P. Gallemore, MD, PhD

Retina Macula Institute

More Information

Responsible Party:	Retina Macula Institute ( Ron P. Gallemore )
Study ID Numbers:	FVF4495s
Study First Received:	September 30, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00764738
Health Authority:	United States: Food and Drug Administration

Keywords provided by Retina Macula Institute:

ARMD
AMD
exudative AMD

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 13, 2009