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Age-related Macular DegenerationPhase 3NCT00788177

Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

A Phase 3 study testing Pegaptanib (Macugen®) in people with Age-related Macular Degeneration, run by Klinikum Ludwigshafen at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the AMD was deemed ineffective. 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?
Pegaptanib (Macugen®)
How many people
10 participants
Where
1 siteGermany
Study dates
Nov 2008to Dec 2012
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

  • Adults aged 50 years and older with neovascular AMD proven by FA
  • Patients who at baseline
  • Have a BCVA letter score in the study eye between 20/40 to 20/320 using an ETDRS chart measured at 4 meters or Snellen equivalent
  • Have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography:
  • Evidence that CNV extends under the geometric center of the foveal avascular zone.
  • Previous state-of-the-art therapy for the disease is deemed ineffective with following characteristics are given:
Show all 11Show fewer
  • Loss of visual acuity (2 or more Snellen lines) in the previous 3 months defined as either OR
  • ≥10% increase in the lesion diameter as assessed by fluorescein angiography in the previous 3 months
  • Ability of subject to understand character and individual consequences of clinical trial.
  • Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
  • Women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry).

Who cannot join

  • Subjects presenting with any of the following criteria will not be included in the trial:
  • Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, retinal vessel occlusion)
  • Had previous vitrectomy surgery for whatsoever reason
  • Are not pseudophakic
  • Have a >50% area of scarring of the whole CNV lesion size as seen in FA
  • Arterial hypertension refractory to medical treatment
Show all 11Show fewer
  • Pregnancy and lactation.
  • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  • Participation in other clinical trials during the present clinical trial or within the last 3 months.
  • Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
  • Suspected or present ocular or periocular infection

Trial locations and contacts

1 site in 1 country.

Lars-Olof Hattenbach, MD contact

+49 (621) 503 3051

hattenbl@klilu.de

Germany1 site, 1 recruiting

  • Department of Ophthalmology, Ludwigshafen hospital

    Ludwigshafen, 67063

    Lars-Olof Hattenbach, MD, +49 (621) 503 3051, Hattenbl@klilu.de

    Lars-Olof Hattenbach, MD

    Recruiting

Other trials in Germany

About this study

Official title: Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)

The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the AMD was deemed ineffective.

Being tested
Pegaptanib (Macugen®)
Keywords
age-related macular degeneration, subretinal injection, Pegaptanib, Macugen
Medical subject headings
Macular Degeneration

What participants receive

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

  • Pegaptanib (Macugen®)Drug

    Also called Macugen®, Pfizer Pharma GmbH

    Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)

What is being measured

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

  1. Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks

    Measured: 54 weeks

  2. Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks

    Measured: week 24 and 54

Secondary outcomes (6)

  1. Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks

    Measured: 54 weeks

  2. Mean change from baseline in at week 12 and 24

    Measured: week 12 and 24

  3. Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54

    Measured: week 24 and 54

  4. Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54

    Measured: week 24 and 54

  5. Change in area of leakage at 12, 24 and 54 weeks

    Measured: weeks 12, 24 and 54

  6. Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks

    Measured: weeks 12, 24 and 54

Timeline

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

  1. First posted10 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionMar 2012 (estimated)
  4. Study completionDec 2012 (estimated)

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00788177
Sponsor's protocol ID
AU-06102G
Status last verified
Jul 2009
First submitted
7 Nov 2008
Last updated
27 Sep 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegaptanib (Macugen®) in people with Age-related Macular Degeneration, run by Klinikum Ludwigshafen at 1 site in Germany.

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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lars-Olof Hattenbach, MD (+49 (621) 503 3051, hattenbl@klilu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks (time frame: 54 weeks). 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 NCT00788177.

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 27 Sep 2011.

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