A non-controlled trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade®) in Exudative Age Related Macular Degeneration.
Completed
- Conditions
- Exudative Age Related Macular Degeneration.Exudatieve leeftijdgebonden Macula Degeneratie
- Registration Number
- NL-OMON20009
- Lead Sponsor
- Erasmus Medisch CentrumDr. Molewaterplein 403015 GD Rotterdam&Oogziekenhuis RotterdamSchiedamse Vest 1803011 BH Rotterdam
- Brief Summary
van Hagen PM, Baarsma GS, van Bilsen CE, Kuijpers RW, van Laar JA, van der Ent M, van Daele PL, Veeger NJ, Vingerling JR, Missotten TO. A noncontrolled trial of anti-TNF-α chimeric monoclonal antibody (infliximab, Remicade®) in exudative age-related macular degeneration. Acta Ophthalmol. 2014; Epub ahead of print Jun 22. PMID: 24953977
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Have the capacity to understand and sign an informed consent form;
2. Men and women > 60 years of age;
Exclusion Criteria
1. Ophthalmic exclusion criteria:
a. Inability to visualize the fundus due to corneal or important lenticular opacities;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute change in visual acuity (VA) versus baseline of the target eye. Target eye for primary endpoint is defined as the eye that is indicated by the patient as the most recent and worsening. VA change will be expressed as the absolute change in number of letters correctly identified at week 0 compared to week 52. VA will be determined as described in Chapter 20 of the Protocol.
- Secondary Outcome Measures
Name Time Method 1. Proportional changes in VA using ETDRS chart;<br /><br>2. Proportion of target eyes that have a change in VA better than a loss of 15 letters on the ETDRS chart;<br /> <br>3. Proportion of target eyes that have a change in VA better than a loss of 30 letters on the ETDRS chart;<br /> <br>4. Time until decrease of VA > 15 letters on ETDRS chart;<br /><br>5. Time until decrease of VA > 30 letters on ETDRS chart;<br /><br>6. Change in contrast sensitivity using Pelli-Robson chart;<br /> <br>7. Change in area of the CNV lesion on photography and fluorescein angiography;<br /><br>8. Change in quality of life measurements.