Macular DegenerationPhase 2RAPNCT00527475
Ranibizumab and Reduced Fluence PDT for AMD
A Phase 2 study testing ranibizumab and verteporfin in people with Macular Degeneration, run by Texas Retina Associates at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- ranibizumab and verteporfin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2007to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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. -
Who cannot join
- 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.
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- Previous vitrectomy
- Media opacities limiting visual acuity, retinal examination, or retinal imaging.
- A lesion where > 50% of the lesion is a pigment epithelial detachment. -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Associated Retinal Consultants
Ann Arbor, Michigan, 49301
Texas Retina Associates
Arlington, Texas, 76012
California Retina Consultants & Research Foundation
Santa Barbara, California, 93103
About this study
Official title: Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration
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.
Read the 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
- Being tested
- ranibizumab, verteporfin
- Keywords
- Anti-VEGF therapy, photodynamic therapy, neovascularization
- Medical subject headings
- Macular Degeneration, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
0.5 mg. given as an intraocular injection
verteporfinDrug
Also called Visudyne
Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ranibizumab; Drug: verteporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.
Measured: 1 year
Secondary outcomes (4)
Percentage of Participants With Retreatments Over One Year
Number of days to retreatment outcome changed to frequency of retreatments at maintenance visits.
Measured: 1 year
Number of Injections Over 12 Months
Additional number of ranibizumab injections given in each group over the 12 months
Measured: 1 year
Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity
Measured: 1 year
Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months
Improvement in OCT (Optical coherent tomography) foveal thickness at 12 months/Number of microns in foveal thickness measurement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Retina Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- David Callanan, MD, Study chair, Texas Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527475
- Sponsor's protocol ID
- RAP AMD Trial
- Acronym
- RAP
- Status last verified
- Nov 2025
- First submitted
- 9 Sep 2007
- Last updated
- 28 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00527475
- Acronym / sponsor ID
- RAP / RAP AMD Trial
- Conditions
- Macular Degeneration
- Keywords
- Anti-VEGF therapy, photodynamic therapy, neovascularization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Texas Retina AssociatesUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Posted 7 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: ranibizumabGroup 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 II | Experimental | Drug: ranibizumab, Drug: verteporfinGroup 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranibizumabAlso: Lucentis0.5 mg. given as an intraocular injection | Drug | Group I, Group II |
| verteporfinAlso: VisudyneStandard dosage of 6 mgs. / meter2 of body surface area given intravenously. | Drug | Group II |
Primary outcome
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.
Time frame: 1 year
4 secondary outcomes
Percentage of Participants With Retreatments Over One Year
Time frame: 1 year
Number of Injections Over 12 Months
Time frame: 1 year
Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity
Time frame: 1 year
Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Callanan, MD study chair
Texas Retina Associates
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ranibizumab and verteporfin in people with Macular Degeneration, run by Texas Retina Associates at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.