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Macular DegenerationPhase 3NCT00121407

Visudyne® in Occult (VIO)

A Phase 3 study testing Visudyne for injection in people with Macular Degeneration, run by QLT Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate that Visudyne therapy in patients who have occult with no classic subfoveal choroidal neovascularization (CNV) lesions will, with an acceptable safety profile, significantly reduce the risk of vision loss compared with placebo (sham treatment). 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?
Visudyne for injection
Type of treatment
Injection or infusion
How many people
364 participants
Where
No sites listed yet
Study dates
Mar 2002to Aug 2005
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Patients are men or women age 50 years or older.
  • Patients must have occult CNV secondary only to AMD in the study eye, without any other concurrent retinal disease present that may also be associated with CNV (e.g., pathologic myopia, ocular histoplasmosis syndrome, etc.). In the case that both eyes are eligible, only one eye will be treated and the decision of which eye will be treated will be made between the patient and physician.
  • Patients must have blood associated with the lesion or must have shown a progression of the disease within the preceding 3 months before randomization to treatment. For the purpose of this study, disease progression is defined as either:
  • a documented loss of vision (six or more letters with the ETDRS chart or at least three lines with a Snellen chart) using best-corrected visual acuity assessments; or
  • documented fluorescein angiographic evidence of a 10% increase in the lesion's greatest linear dimension.
  • Patients must have lesions in the study eye with the following characteristics as determined by fluorescein angiography:
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  • Evidence that occult CNV involves the geometric center of the foveal avascular zone;
  • The lesion has only occult CNV with no classic CNV;
  • The area of occult CNV must occupy at least 50% of the total lesion.
  • Patients must have a best-corrected visual acuity score in the study eye between 73 and 34 letters (approximate Snellen equivalent of 20/40 to 20/200), inclusive. Visual acuity will be measured with an ETDRS chart using the procedure developed for the TAP/VIP studies.
  • Patients must meet at least one of the following criteria:
  • CNV lesion ≤4 MPS disc areas;
  • Visual acuity score <65 letters.
  • Female patients of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at baseline and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD); oral, implanted or injected contraceptives; and barrier methods with spermicide.
  • Patients must sign an approved informed consent that complies with relevant regulatory requirements prior to undergoing any study-related procedures.

Who cannot join

  • Patients with a greatest linear dimension (GLD) of the entire lesion that exceeds 5400 microns
  • Patients with a lesion size >6 MPS disc area (15.24 mm2)
  • Patients with a CNV lesion size that is >4 MPS disc areas associated with a best-corrected visual acuity score that is >=65 letters (approximate Snellen equivalent of 20/50 or better) at the initial visit.
  • Patients who have a known hypersensitivity/allergy to Visudyne, porfimer sodium, or other porphyrins; porphyria or other porphyrin sensitivity; or hypersensitivity to sunlight or bright artificial light.
  • Patients who have the following in the study eye: a tear (rip) of the RPE; a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen); idiopathic parafoveal telangiectasis, retinal lesion anastomosis, or central serous retinopathy.
  • Patients with a known allergy to fluorescein dye.
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  • Patients who have any additional ocular diseases which have irreversibly compromised or, during follow-up, could likely compromise the visual acuity of the study eye including amblyopia, elevated intraocular pressure (≥30 mm Hg), anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy or cataract (lens or capsule) obscuring easy identification of the CNV lesion on biomicroscopy or fluorescein angiography.
  • Patients who are unable to be photographed to document CNV, e.g., due to media opacity, cataract obscuring the CNV, allergy to fluorescein dye, or lack of venous access.
  • Patients who have had treatment for CNV in the study eye with photodynamic therapy (PDT), transpupillary thermotherapy (TTT), or other local treatment (such as submacular surgery). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
  • Patients who are participating in any other clinical study or are receiving, or have received any experimental systemic treatment for AMD (e.g., retinoic acid, thalidomide) or any other investigational new drug within 12 weeks prior to the start of study treatment.
  • Patients who have undergone intraocular surgery within the last two months or Nd:YAG capsulotomy within the last month in the study eye.
  • Patients who have a history of moderate to severe hepatic impairment (patients with this history may be included if laboratory tests are performed and results indicate that they are within the normal limits).

About this study

Official title: A Randomized, Placebo-Controlled, Double-Masked, Multicenter, Phase III Study of the Effect of Visudyne Therapy in Occult With No Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD): Visudyne in Occult (VIO)

The purpose of this study is to demonstrate that Visudyne therapy in patients who have occult with no classic subfoveal choroidal neovascularization (CNV) lesions will, with an acceptable safety profile, significantly reduce the risk of vision loss compared with placebo (sham treatment).

Read the detailed description

This is a randomized, placebo-controlled, double masked, multicenter, Phase III study. Patients will be stratified by study center and randomized to Visudyne therapy or placebo in a 2:1 ratio, respectively. Patients will receive either a single intravenous dose of Visudyne or placebo followed 15 minutes after the start of the infusion by light application. Follow-up visits will occur every three months (+/- 2 weeks) for the duration of the study. Re-treatment may be administered every three months (through the Month 21 visit) if evidence of CNV leakage is detected by fluorescein angiography (as judged by the Investigator).

At baseline and at each follow-up visit, patients will undergo the following assessments: ophthalmic examination, best-corrected visual acuity, color fundus photography, and fluorescein angiography. Indocyanine green (ICG) angiography will be conducted at baseline, Month 12, and Month 24. Optical coherence tomography (OCT) will be done at baseline, Month 3, Month 6, Month 12, and Month 24. Adverse events and concomitant medications will be assessed throughout the study.

Being tested
Visudyne for injection
Keywords
Age Related Macular Degeneration (AMD), Photodynamic Therapy (PDT), Visudyne
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visudyne for injectionDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy variable is the patient responder rate. The patient responder rate has two definitions as described below:

  2. • The proportion of patients who lose less than 15 letters (<3 lines) of best-corrected visual acuity in the study eye from baseline

  3. • The proportion of patients who lose fewer than 30 letters (<6 lines) of best-corrected visual acuity in the study eye from baseline

Secondary outcomes (3)

  1. • The proportion of patients whose best-corrected visual acuity decreased to fewer than 34 letters (approximate Snellen equivalent of 20/200)

  2. • Change from baseline in visual acuity score

  3. • Cumulative proportion of patients who develop predominantly classic CNV in the study eye (identified by the Investigator and confirmed by a central reading center).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2005 (estimated)
  2. Study startMar 2002
  3. Study completionAug 2005

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
364 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121407
Sponsor's protocol ID
BPD OCR 013 (VIO)
Status last verified
Jul 2005
First submitted
12 Jul 2005
Last updated
21 Jul 2005
Results posted
No

Publications

  • Kaiser PK; Visudyne In Occult CNV (VIO) study group. Verteporfin PDT for subfoveal occult CNV in AMD: two-year results of a randomized trial. Curr Med Res Opin. 2009 Aug;25(8):1853-60. doi: 10.1185/03007990903038616.

    PubMed 19530976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Visudyne for injection in people with Macular Degeneration, run by QLT Inc..

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 15 inclusion and 12 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 21 Jul 2005. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 primary efficacy variable is the patient responder rate. The patient responder rate has two definitions as described below:. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00121407, which also lists 1 linked publication.

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 21 Jul 2005.

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