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Neovascular Age Related Macular DegenerationPhase 3NCT00685100

Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone

A Phase 3 study testing PDT plus intravitreal triamcinolone in people with Neovascular Age Related Macular Degeneration, run by Medical University of Vienna.

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

Background: To identify characteristic morphological changes of the retina, their change over time and the association with visual function after combined photodynamic therapy (PDT) and intravitreal triamcinolone (IVTA). Read more about this study

Who is it for?
Ages 50 to 85 years
What is being tested?
PDT plus intravitreal triamcinolone
How many people
40 participants
Where
No sites listed yet
Study dates
Jan 2004to Jan 2007
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • cnv secondary to age related macular degeneration

Who cannot join

  • glaucoma, diabetic retinopathy

About this study

Background: To identify characteristic morphological changes of the retina, their change over time and the association with visual function after combined photodynamic therapy (PDT) and intravitreal triamcinolone (IVTA).

Methods: In this retrospective study, 40 patients (40 eyes) were treated with PDT and same day IVTA. Optical coherence tomography (OCT), fluorescein angiography (FA) and evaluation of distance visual acuity (VA) were performed. Main outcome measures were the anatomical changes within intra- and subretinal compartments and their detailed analysis and grading.

Being tested
PDT plus intravitreal triamcinolone
Keywords
IVTA; CNV; age-related macular degeneration; PDT
Medical subject headings
Choroidal Neovascularization, Macular Degeneration

What participants receive

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

  • PDT plus intravitreal triamcinoloneOther

    PDT plus intravitreal triamcinolone

What is being measured

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

  1. visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)

    "Changes in macular sensitivity after reduced fluence photodynamic therapy combined with intravitreal triamcinolone" Mean DLT decreased from 4.71 dB at baseline to 3.45 dB after 12 months in the SPDT + IVTA group (mean decrease 1.26 dB; p > 0.05) and from 5.42 dB to 4.92 dB in the RPDT + IVTA group (mean decrease 0.5 dB; p > 0.05). Absolute and relative scotoma sizes remained stable in both groups at 12 months (mean change 0 and -0.6 test-points; p > 0.05). Mean DLT values and absolute scotoma sizes correlated well with early and late leakage areas in FA (r = -0.45 to -0.80, p < 0.02).

    With regard to MS, RPDT + IVTA did not show significant benefits over SPDT + IVTA at 12 months. Macular sensitivity correlated well with angiographic outcomes.

    Measured: Day 1, Week 1, 4 and 12

  2. visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)

    "Reduced fluence versus standard photodynamic therapy in combination with intravitreal triamcinolone: short-term results of a randomised study" Baseline characteristics were well balanced in both groups (p>0.05). At week 12, patients in group A had a mean loss of -3.7 letters compared with a gain of 3.4 letters in group B (p = 0.04, between both groups). Both treatment groups showed a similar course regarding CRT as well as MS (p>0.05). In 70% (14/20) of group A and 15% (3/20) of group B, a choroidal hypoperfusion in the area of treatment was observed after treatment (p<0.001). In 70% of group A and 55% of group B, a repeat treatment was indicated at week 12 (p = 0.55).

    At month 3, the rPDT+IVTA group showed a significantly better visual outcome, less alteration of the choroid and a trend for lower recurrence rate than the sPDT+IVTA group. Further follow-up of this study will provide information on long-term functional results and treatment durability.

    Measured: Day 1, week 1, 4 and 12

Timeline

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

  1. First posted28 May 2008 (estimated)
  2. Study startJan 2004
  3. Primary completionJan 2006
  4. Study completionJan 2007

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00685100
Sponsor's protocol ID
002
Status last verified
May 2008
First submitted
23 May 2008
Last updated
15 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PDT plus intravitreal triamcinolone in people with Neovascular Age Related Macular Degeneration, run by Medical University of Vienna.

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 1 inclusion and 1 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 15 Apr 2015. 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?

visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS) (time frame: Day 1, Week 1, 4 and 12). The study lists 2 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 NCT00685100.

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 15 Apr 2015.

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