AzTrials
AzTrials

Age Related Macular DegenerationPhase 3NCT01570608

Lucentis KAV Study

A Phase 3 study testing Ranibizumab and Verteporfin in people with Age Related Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 3 sites in Austria.

Completed

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

Official record
Search all trials

Trial summary

Ranibizumab has been proven to be effective in large multicentre studies. However, the injections have to be repeated monthly. A combined therapy with the established photodynamic therapy might even be more effective, less intravitreal injections might be necessary due to a synergistic effect. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age Related 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
51 participants
Where
3 sitesAustria
Study dates
Mar 2007to Aug 2011
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

  • BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart measured at 4 meters or Snellen equivalent
  • CNV lesion of any type in the study eye which meets all the following characteristics as determined by fluorescein angiography:
  • Evidence that CNV extends under the geometric center of the foveal avascular zone.
  • The area of the CNV must occupy at least 50% of the total lesion.
  • The lesion must be ≤ 5400 microns in greatest linear dimension (GLD)
  • For occult with no classic CNV, additionally recent disease progression as assessed by the Investigator is required defined as having at least one of the following criteria:
Show all 10Show fewer
  • Blood associated with the lesion at baseline
  • Loss of VA in the previous 3 months defined as either ≥ 5 letters (ETDRS equivalent) as determined by protocol refraction and protocol measurements, or 2 or more lines using a Snellen or equivalent chart by standard examinations. ≥ 10% increase in the greatest diameter of the lesion in the previous 3 months as assessed by fluorescein angiography
  • Willing to return for scheduled visits for a 12 month period
  • Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study

Who cannot join

  • Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes
  • Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy
  • Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
  • Focal laser photocoagulation (juxta-, extra- or subfoveal) in the study eye
  • Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as "low dose" up to 100 mg qd for prophylaxis of MI and/or stroke is permitted during study
  • Current use or of likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded
Show all 16Show fewer
  • History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.)
  • History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with topical anti-glaucomatous mediation).
  • Aphakia or absence of the posterior capsule in the study eye
  • Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
  • Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
  • Presence of a retinal pigment epithelial tear involving the macula in the study eye
  • Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Any active infection involving an eyeball adnexa
  • Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

Trial locations and contacts

3 sites in 1 country.

Austria3 sites

  • Department of OPhthalmology Medical center east

    Vienna, State of Vienna, A1030

  • Department of Ophthalmology Rudolf foundation Clinic

    Vienna, State of Vienna, A1030

  • Department of Ophthalmology, Hospital Hietzing

    Vienna, State of Vienna, A1030

Other trials in Austria

About this study

Official title: Comparison of Ranibizumab (Lucentis) Monotherapy Versus Combination of Ranibizumab (Lucentis) With Photodynamic Therapy (Verteporfin) in Patients With Subfoveal Choroidal Neovascularisation Due to Age-Related Macular Degeneration - a Pilot Study

Ranibizumab has been proven to be effective in large multicentre studies. However, the injections have to be repeated monthly. A combined therapy with the established photodynamic therapy might even be more effective, less intravitreal injections might be necessary due to a synergistic effect.

The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in combination with verteporfin photodynamic therapy under a new time regime is an effective, safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV) secondary to Age-Related Macular Degeneration (AMD).

Being tested
Ranibizumab, Verteporfin
Keywords
Ranibizumab, Bevacizumab, Verteporfin, age-related macular degeneration
Medical subject headings
Macular Degeneration

What participants receive

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

  • RanibizumabDrug

    intravitreal injection 3 monthly injections thereafter as needed

  • VerteporfinDrug

    Verteporfin photodynamic therapy standard fluence

Study groups in NCT01570608
Study groupRoleWhat they receive
monotherapy armActive comparatorpatients receiving 3 initial Ranibizumab injections, thereafter as needed
Receives: Drug: Ranibizumab
combined treatment armActive comparatorNot described
Receives: Drug: Ranibizumab; Drug: Verteporfin

What is being measured

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

  1. number of injections

    Comparision of the number of required retreatments between the groups

    Measured: baseline-month 12

Secondary outcomes (3)

  1. number of AE, SAE

    number of AE and SAE

    Measured: 12 months

  2. central retinal thickness

    central retinal thickness measured by OCT

    Measured: baseline-month 12

  3. distance acuity

    change of disance acuity measured by ETDRS letter scores

    Measured: baseline-month 12

Timeline

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

  1. First posted4 Apr 2012 (estimated)
  2. Study startMar 2007
  3. Primary completionAug 2011
  4. Study completionAug 2011

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
Single blind
Who is masked
Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01570608
Sponsor's protocol ID
EK 06-233-0107
Other IDs
2006-006760-28
Status last verified
Apr 2012
First submitted
1 Apr 2012
Last updated
4 Apr 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab and Verteporfin in people with Age Related Macular Degeneration, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 3 sites in Austria.

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 16 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 4 Apr 2012. 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 Austria. 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 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?

number of injections (time frame: baseline-month 12). 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 NCT01570608.

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 4 Apr 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in