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Completed

NCT Number: NCT00527475

Ranibizumab and Reduced Fluence PDT for AMD

Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Retina Consultants & Research Foundation, Santa Barbara, California, United States

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About this study

A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. The other group will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. Re-treatment will be determined by the individual investigator based on visual acuity, retinal thickness as measured by optical coherence tomography (OCT), and fluorescein angiography. Visual acuity and OCT measurements will be performed by masked examiners.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willingness to sign informed consent.
  • Age greater than 50.
  • Evidence of macular degeneration in the form of drusen in either eye.
  • Visual acuity of 20/25 to 20/800.
  • Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:
  • Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)
  • Documented enlargement of lesion on FA
  • Increase of 50 microns or more in the central subfield on OCT
  • New blood
  • Total active lesion must be less than 12 disc areas in size. -

Exclusion criteria

  • Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision
  • Previous treatment of the enrolled eye for CNV
  • Intraocular surgery within 6 weeks of enrollment
  • Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye
  • Known hypersensitivity to verteporfin
  • Medical condition that would preclude regular follow-up for one year.
  • Previous vitrectomy
  • Media opacities limiting visual acuity, retinal examination, or retinal imaging.
  • A lesion where > 50% of the lesion is a pigment epithelial detachment. -

Treatment and study plan

ranibizumab

Drug

0.5 mg. given as an intraocular injection

Other names: Lucentis

Verteporfin

Drug

Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.

Other names: Visudyne

Primary outcomes

  1. The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.

    Time frame: 1 year

Secondary outcomes

  1. Percentage of Participants With Retreatments Over One Year

    Time frame: 1 year

    Number of days to retreatment outcome changed to frequency of retreatments at maintenance visits.

  2. Number of Injections Over 12 Months

    Time frame: 1 year

    Additional number of ranibizumab injections given in each group over the 12 months

  3. Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity

    Time frame: 1 year

  4. Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months

    Time frame: 1 year

    Improvement in OCT (Optical coherent tomography) foveal thickness at 12 months/Number of microns in foveal thickness measurement

Sponsors and collaborators

Lead sponsor

Texas Retina Associates

Other

Collaborators

  • Novartis

Registry information

Official study title

Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration

Acronym: RAP

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 11, 2007
Registry last updated
Nov 28, 2025

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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