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

Last updated: May 29, 2024
Sponsor: Asociación para Evitar la Ceguera en México
Overall Status: Trial Not Available

Phase

2/3

Condition

Geographic Atrophy

Macular Degeneration

Treatment

intravitreal injection of ranibizumab

intravitreal injection of triamcinolone

photodynamic therapy

Clinical Study ID

NCT00930189
APEC-0031
  • Ages 20-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subfoveal choroidal neovascularization (CNV) secondary to age-related maculardegeneration (AMD)

  • Any visual acuity

Exclusion

Exclusion Criteria:

  • Previous treatment

  • Glaucoma

Study Design

Treatment Group(s): 3
Primary Treatment: intravitreal injection of ranibizumab
Phase: 2/3
Study Start date:
April 01, 2006
Estimated Completion Date:
September 30, 2006

Study 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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Connect with a study center

  • Centro Medico Isemmym

    Metepec, Estado-de-Mexico 52140
    Mexico

    Site Not Available

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