Ranibizumab and Reduced Fluence PDT for AMD

NCT00527475 | Completed Phase 2 Results

• 1 other identifier: RAP AMD Trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Macular Degeneration

Keywords

Anti-VEGF therapy; photodynamic therapy; neovascularization

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (4)

• Percentage of Participants With Retreatments Over One Year

  1 year

• Number of Injections Over 12 Months

  1 year

• Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity

  1 year

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

  1 year

Study Arms (2)

Group I

ACTIVE COMPARATOR

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.

Drug: ranibizumab

Group II

EXPERIMENTAL

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.

Drug: ranibizumab; Drug: verteporfin

Interventions

ranibizumab DRUG

0.5 mg. given as an intraocular injection

Also known as: Lucentis

Group I; Group II

verteporfin DRUG

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

Also known as: Visudyne

Group II

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Texas Retina Associates: lead
• Novartis: collaborator

Study Sites (3)

California Retina Consultants & Research Foundation

Santa Barbara, California, 93103, United States

Location

Associated Retinal Consultants

Ann Arbor, Michigan, 49301, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Neovascularization, Pathologic

Interventions

Ranibizumab; Verteporfin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: David Callanan, MD
• Organization: Texas Retina Associates

dcallanan@texasretina.com

817-261-9625

Study Officials

• David Callanan, MD

  Texas Retina Associates

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2007
• First Posted: September 11, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 28, 2025
• Results First Posted: June 7, 2013

Record last verified: 2025-11

Locations

US (3)