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A Phase I/II, Single-Masked Multicenter Study of the Safety, Tolerability and Efficacy of Multiple Dose Intravitreal Injections of rhuFabV2 in Combination with Verteporfin Photodynamic Therapy (Visudyne) in Subjects with Neovascular Age Related Macular Degeneration

Principal Investigator

Ronald Gentile, M.D.   

Enrollment Status    

Completed

Objective 

To evaluate the safety, tolerability and efficacy of multiple dose intravitreal injections of rhuFabV2 in combination with Verteporfin Photodynamic Therapy (PDT with Visudyne) in subjects with neovascular age related macular degeneration.

Eligibility 

Patients of either gender, aged 50 years or above, diagnosed with classic subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in study eye, where treatment with verteporfin is anticipated or expected. Patients with no more than three prior PDT in study eye are eligible.

Study Results

At month 24, 88% of ranibizumab + PDT patients had lost <15 letters from baseline VA (vs 75% for PDT alone), 25% had gained >or=15 letters (vs 7% for PDT alone), and the two treatment arms differed by 12.4 letters in mean VA change (P < .05 for all between-group differences). The VA benefit of adding ranibizumab to PDT in year one persisted through year two. On average, ranibizumab + PDT patients exhibited less lesion growth and greater reduction of CNV leakage and subretinal fluid accumulation, and required fewer PDT retreatments, than PDT-alone patients (mean = 0.4 vs 3.0 PDT retreatments). Endophthalmitis and serious intraocular inflammation occurred, respectively, in 2.9% and 12.4% of ranibizumab + PDT patients and 0% of PDT-alone patients. Incidences of serious nonocular adverse events were similar in the two treatment groups.

Conclusions

Through two years, ranibizumab + PDT was more effective than PDT alone and had a low rate of associated adverse events.

For more information: ClinicalTrials.gov

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