Comparative Study With Photodynamic Therapy And Triamcinolone Versus Photodynamic Therapy, Triamcinolone And Ranibizumab In Patients With Subfoveal Choroidal Neovascularization

Phase 2

Withdrawn

• Conditions: Subfoveal Choroidal Neovascularization

• Registration Number: NCT00930189
• Lead Sponsor: Asociación para Evitar la Ceguera en México

Brief Summary

The purpose of this study is to compare the efficacy of photodynamic therapy with verteporfin (PDT) and IVTA vs triple therapy (TT) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

The investigators designed a prospective, comparative, randomized, double blind, controlled study. 15 patients with classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized. Triple therapy can potentially offer a new treatment modality for choroidal neovascularization in patients with macular degeneration and other diseases.

Detailed Description

Purpose: To compare the efficacy of photodynamic therapy with verteporfin (PDT) and IVTA vs triple therapy (TT) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Methods: Prospective, comparative, randomized, double blind, controlled study. 15 patients with classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized. Group 1: receive PDT followed by 4 mg IVTA (n=7) or group 2: TT (triple Therapy) PDT followed by 4 mg IVTA + 0.5 mg Ranibizumab (n=8).The main outcome measures were visual acuity (VA), mean change in lesion size, mean change in foveal thickness, retreatment rate and the incidence and severity of adverse events.

Results: At 6 months 5 of 7 patients (71.4%) of group 1 and 8 of 8 patients (100% ) of group 2 had lost fewer than 15 letters (P\<.001). Three patients (37.5%) of group 2 had an improvement of 3 lines or more. Lesion type, patient age, and lesion size had no influence on the outcome, but baseline VA had a statistically significant effect (P =.006). The median number of treatments in both groups was one. The 28% of PDT-triamcinolone group and 25% of triple therapy group had an increase in intraocular pressure (IOP) that required therapy. Progression or development of cataract was observed in 14.2 % in PDT- IVTA group and 12.5% in Triple therapy group. There were no cases of endophthalmitis. No cardiac or cerebrovascular accidents where presented.

Conclusions: The combination of PDT, intravitreal triamcinolone acetonide and intravitreal ranibizumab is a safe treatment option for neovascular AMD and prevents a considerable decrease in VA. In our patients it seems to be superior than combinated therapy with PDT and triamcinolone.

Clinical Relevance: Triple therapy can potentially offer a new treatment modality for choroidal neovascularization in patients with macular degeneration and other diseases.

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Study Timeline

• Study Start: 2006-04
• Primary Completion: 2006-04
• Study Completion: 2006-09
• Study First Submitted: 2006-12-01
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
• Any visual acuity

Exclusion Criteria

• Previous treatment
• Glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The main outcome measures were visual acuity (VA)
mean change in foveal thickness
mean change in lesion size

Secondary Outcome Measures

Name	Time	Method
retreatment rate
the incidence and severity of adverse events

Trial Locations

Locations (1)

Centro Medico Isemmym; 🇲🇽 Metepec, Estado-de-Mexico, Mexico