Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Retina Macula Institute |
---|---|
Information provided by: | Retina Macula Institute |
ClinicalTrials.gov Identifier: | NCT00764738 |
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 |
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 |
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. |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lillian Chen | 310-944-9393 | lillian.rmi@gmail.com |
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 |
Principal Investigator: | Ron P. Gallemore, MD, PhD | Retina Macula Institute |
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 |
ARMD AMD exudative AMD |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases Retinal degeneration |