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OpenTrials
Completed

NCT Number: NCT00426998

Combination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD

The purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95819, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients are men or women of age 55 or older
  • Patients have subfoveal CNV due to AMD with lesion size less than or equal to 9 MPS DA
  • patients have not received previous treatment for subfoveal CNV due to AMD.
  • Patients have a visual acuity between 20/40 and 20/320-

Exclusion criteria

  • Subjects who have received previous treatment for subfoveal CNV, in their study eye including prior PDT, transpupillary thermotherapy (TTT), submacular surgery, drug therapies such as Macugen or other anti-angiogenic compounds, or other local treatment. Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
  • Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
  • Patients who use medications that may induce photosensitivity.
  • Patients who have undergone YAG capsulotomy within the last month.
  • Subjects currently involved in any experimental procedure within the last 12 weeks.
  • Female patients who are pregnant, fecund or breast-feeding.

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Treatment and study plan

Verteporfin

Drug

Bevacizumab

Drug

Primary outcomes

  1. percentage of patients losing 3 or more lines of visual acuity

  2. percentage of patients gaining 3 or more lines of visual acuity

  3. mean change from baseline in visual acuity

  4. OCT evidence of active CNV leakage

  5. fluorescein angiographic evidence of active CNV leakage

  6. number of retreatments

Sponsors and collaborators

Lead sponsor

Retinal Consultants Medical Group

Other

Registry information

Official study title

A 24 Month Randomized, Double-Masked, Single Center, Phase II Study Comparing Photodynamic Therapy With Verteporfin (Visudyne)Plus Two Different Timing Regimens of Intravitreal Bevacizumab (Avastin) Given 1 Week Prior to or 1 Week Following Photodynamic Therapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

Important dates

Study start
2006
First posted
Jan 26, 2007
Registry last updated
Jan 26, 2007

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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