A Phase 2 interventional study of ranibizumab and verteporfin in Macular Degeneration, sponsored by Texas Retina Associates. Completed at 3 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Texas Retina Associates · Phase 2, Interventional, and Treatment
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.
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 60 is close to the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Texas Retina Associates is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
0.5 mg. given as an intraocular injection
Also known as: Lucentis
Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.
Also known as: Visudyne
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.
Time frame: 1 year
Percentage of Participants With Retreatments Over One Year
Number of days to retreatment outcome changed to frequency of retreatments at maintenance visits.
Time frame: 1 year
Number of Injections Over 12 Months
Additional number of ranibizumab injections given in each group over the 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
Improvement in OCT (Optical coherent tomography) foveal thickness at 12 months/Number of microns in foveal thickness measurement
Time frame: 1 year
| Milestone | Ranibizumab | Reduced Fluence PDT & Ranibizumab |
|---|---|---|
| Started | 30 | 30 |
| Completed | 27 | 29 |
| Not completed | 3 | 1 |
| percentage of participants | Group I | Group II |
|---|---|---|
| The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. | 22 | 14 |
Number of days to retreatment outcome changed to frequency of retreatments at maintenance visits.
| % of subjects requiring additional injec | Group I | Group II |
|---|---|---|
| Percentage of Participants With Retreatments Over One Year | 33 | 21 |
Additional number of ranibizumab injections given in each group over the 12 months
| injections | Group I | Group II |
|---|---|---|
| Number of Injections Over 12 Months | 6.8 ± 2.49 | 3.0 ± 2.43 |
| percentage | Group I | Group II |
|---|---|---|
| Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity | 33 | 31 |
Improvement in OCT (Optical coherent tomography) foveal thickness at 12 months/Number of microns in foveal thickness measurement
| microns | Group I | Group II |
|---|---|---|
| Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months | 91.4 ± 12.8 | 104.1 ± 9.0 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Group II | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Group I | Group II | Total |
|---|---|---|---|
| Mean | 79.1 ± 8.35 | 79.3 ± 7.23 | 79.2 ± 7.72 |
| Sex: Female, Male(Participants) | Group I | Group II | Total |
|---|---|---|---|
| Female | 14 | 18 | 32 |
| Male | 16 | 12 | 28 |
| Region of Enrollment(participants) | Group I | Group II | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
The record gives a start of May 2007, a primary completion of Jan 2010 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2013, 3 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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