A Phase 4 interventional study of Ranibizumab and Ranibizumab plus Photodynamic therapy in Age-Related Macular Degeneration, sponsored by Illinois Retina Associates. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-03-28.
Sponsored by Illinois Retina Associates · Phase 4, Interventional, and Treatment
This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group).
The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months.
The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.
1,490 studies on the registry are indexed under Macular Degeneration; 208 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 993 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Illinois Retina Associates is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Ranibizumab
Drug: Ranibizumab plus Photodynamic therapy
Ranibizumab 0.5 mg
Also known as: Lucentis
Drug page: Ranibizumab
Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)
Also known as: Lucentis, Visudyne
To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.
Time frame: 1 year
Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.
Time frame: 1 year
Determination of change in visual acuity from baseline.
Time frame: 1 year
Determination of change in retinal thickness by optical coherence tomography (OCT).
Time frame: 1 year
Determination of change in angiographic leakage from CNV.
Time frame: 1 year
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ranibizumab
Illinois Retina Associates