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NCT Number: NCT00473642

Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.

The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.

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Key information

Conditions

Age-Related Maculopathy Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eagle Mountain Vision

Tulsa, Oklahoma, 74132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female Patients > 50 years of age.
  • Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.
  • Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.
  • If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye.
  • Patients must be able and willing to provide written informed consent.

Exclusion criteria

  • Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.
  • Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.
  • Choroidal neovascular membrane greater than 9 disc diameters in size.
  • Previous posterior vitrectomy in the study eye.
  • Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.
  • Pregnant women or premenopausal women not using adequate contraception.
  • History of allergy to fluorescein, Visudyne, Lucentis.
  • Inability to comply with study or follow up procedures.

Treatment and study plan

ranibizumab

Drug

intravitreal administered ranibizumab 0.5 mg in 0.05 mL

Other names: Lucentis

Verteporfin

Drug

Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)

Other names: Visudyne

Primary outcomes

  1. Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months

    Time frame: 12 months

    Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.

  2. Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol

    Time frame: 12 months

    Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.

Secondary outcomes

  1. Time to First Retreatment After Loading Doses

    Time frame: 12 months

  2. Average Number of PDT Retreatments Over 12 Months

    Time frame: 12 months

  3. Central Macular Thickness Reduction on OCT

    Time frame: 12 months

  4. Average Number of Ranibizumab Retreatments Over 12 Months

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Collaborators

  • Novartis

Registry information

Official study title

A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne® (Verteporfin) in Combination With Lucentis™ (Ranibizumab) for the Treatment of Age-Related Macular Degeneration

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
May 15, 2007
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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