N/A
N=26
Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration
Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00539734 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Height (Amplitude) of Multifocal ERG Signal — 2.859 nanovolt/degree^2 — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ranibizumab (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Prince of Songkla University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Height (Amplitude) of Multifocal ERG Signal |
2.859 | <0.05 sig |
| PRIMARY Time to Response (Implicit Time) of Multifocal ERG Signal |
31.621 | — |
| SECONDARY Postoperative Complication |
— | — |
Summary
Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.
Eligibility Criteria
Inclusion Criteria
- Age 45 years and above
- Clinical diagnosis of wet AMD
- First injection of ranibizumab protocol
- Best corrected visual acuity 20/32 - 20/320
- Consent form obtained
Exclusion Criteria
- Previously treated wet AMD patients
- Patients with other ocular diseases which can cause abnormal ERG such as glaucoma, uveitis or retinitis pigmentosa, etc.
- Pregnancy
- History of seizure
Data sourced from ClinicalTrials.gov (NCT00539734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.