Ranibizumab and Reduced Fluence PDT for AMD

NCT ID: NCT00527475

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I

Group I 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.

Group Type: ACTIVE_COMPARATOR

ranibizumab

Intervention Type: DRUG

0.5 mg. given as an intraocular injection

Group II

Group II 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.

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

0.5 mg. given as an intraocular injection

verteporfin

Intervention Type: DRUG

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

Interventions

ranibizumab

0.5 mg. given as an intraocular injection

Intervention Type: DRUG

verteporfin

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

Intervention Type: DRUG

Other Intervention Names

Lucentis; Visudyne

Eligibility Criteria

Inclusion Criteria

1. Willingness to sign informed consent.

2. Age greater than 50.

3. Evidence of macular degeneration in the form of drusen in either eye.

4. Visual acuity of 20/25 to 20/800.

5. Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:

1. Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)

2. Documented enlargement of lesion on FA

3. Increase of 50 microns or more in the central subfield on OCT

4. New blood

6. Total active lesion must be less than 12 disc areas in size. -

Exclusion Criteria

1. Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision

2. Previous treatment of the enrolled eye for CNV

3. Intraocular surgery within 6 weeks of enrollment

4. Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye

5. Known hypersensitivity to verteporfin

6. Medical condition that would preclude regular follow-up for one year.

7. Previous vitrectomy

8. Media opacities limiting visual acuity, retinal examination, or retinal imaging.

9. A lesion where > 50% of the lesion is a pigment epithelial detachment. -

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Texas Retina Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Callanan, MD

Role: STUDY_CHAIR

Texas Retina Associates

Locations

California Retina Consultants & Research Foundation

Santa Barbara, California, United States

Associated Retinal Consultants

Ann Arbor, Michigan, United States

Texas Retina Associates

Arlington, Texas, United States

Countries

United States

Other Identifiers

RAP AMD Trial

Identifier Type: -

Identifier Source: org_study_id