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Diabetic RetinopathyPhase 2DEGASNCT00701181

Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema

A Phase 2 study testing Laser Treatment, PF-04523655 high and PF-04523655 middle in people with Diabetic Retinopathy and Diabetes Complications, run by Quark Pharmaceuticals at 53 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy, Diabetes Complications
What is being tested?
Laser Treatment, PF-04523655 high and PF-04523655 middle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
53 sitesin 8 countries
Study dates
Jun 2008to Jan 2011
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye.

Who cannot join

  • Proliferative Diabetic Retinopathy in the Study Eye.
  • Subjects Receiving Concomitant Intravitreal Anti-VEGF Therapy.

Trial locations and contacts

53 sites in 8 countries.

53 sites in 8 countries

United States26 sites

  • Pfizer Investigational Site

    ‘Aiea, Hawaii, 96701

  • Pfizer Investigational Site

    Augusta, Georgia, 30909

  • Pfizer Investigational Site

    Baltimore, Maryland, 21287

  • Pfizer Investigational Site

    Boston, Massachusetts, 02111

  • Pfizer Investigational Site

    Boston, Massachusetts, 02215

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28210

  • Pfizer Investigational Site

    Chicago, Illinois, 60637

  • Pfizer Investigational Site

    Corpus Christi, Texas, 78413

  • Pfizer Investigational Site

    Henderson, Nevada, 89052

  • Pfizer Investigational Site

    Henderson, Nevada, 89074

  • Pfizer Investigational Site

    High Point, North Carolina, 27262

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46290

  • Pfizer Investigational Site

    Lakeland, Florida, 33805

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89109

  • Pfizer Investigational Site

    Mesa, Arizona, 85210

  • Pfizer Investigational Site

    Meza, Arizona, 85210

  • Pfizer Investigational Site

    Mountain View, California, 94040

  • Pfizer Investigational Site

    New Albany, Indiana, 47150

  • Pfizer Investigational Site

    Peoria, Arizona, 85381

  • Pfizer Investigational Site

    Phoenix, Arizona, 85014

  • Pfizer Investigational Site

    Phoenix, Arizona, 85016

  • Pfizer Investigational Site

    Portsmouth, New Hampshire, 03801

  • Pfizer Investigational Site

    Rapid City, South Dakota, 57701

  • Pfizer Investigational Site

    Statesville, North Carolina, 28677

  • Pfizer Investigational Site

    Winston-Salem, North Carolina, 27157

  • Pfizer Investigational Site

    Winter Haven, Florida, 33880

Other trials in United States

Italy7 sites

  • Pfizer Investigational Site

    Milan, 20122

  • Pfizer Investigational Site

    Milan, 20132

  • Pfizer Investigational Site

    Milan, 20157

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Roma, 00168

  • Pfizer Investigational Site

    Roma, 00198

  • Pfizer Investigational Site

    Udine, 33100

Other trials in Italy

United Kingdom6 sites

  • Pfizer Investigational Site

    Bristol, BS1 2LX

  • Pfizer Investigational Site

    Bristol, BS2 8HW

  • Pfizer Investigational Site

    Frimley, Camberley, Surrey, GU15 3UW

  • Pfizer Investigational Site

    Liverpool, L7 8XP

  • Pfizer Investigational Site

    Sheffield, S10 2JF

  • Pfizer Investigational Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Israel5 sites

  • Pfizer Investigational Site

    Kfar Saba, 44281

  • Pfizer Investigational Site

    Petah Tikva, 49100

  • Pfizer Investigational Site

    Tel Aviv, 64239

  • Pfizer Investigational Site

    Tel HaShomer, 52621

  • Pfizer Investigational Site

    Tsrifin, 70300

Other trials in Israel

India4 sites

  • Pfizer Investigational Site

    Ahmedabad, 380 004

  • Pfizer Investigational Site

    Bangalore, 560 085

  • Pfizer Investigational Site

    Bhubaneswar, Odisha, 751 024

  • Pfizer Investigational Site

    New Delhi, 110 029

Other trials in India

Germany3 sites

  • Pfizer Investigational Site

    Freiburg im Breisgau, 79106

  • Pfizer Investigational Site

    Leipzig, 04103

  • Pfizer Investigational Site

    Münster, 48145

Other trials in Germany

Denmark1 site

  • Pfizer Investigational Site

    Glostrup Municipality, 2600

Other trials in Denmark

Peru1 site

  • Pfizer Investigational Site

    Lima, Lima Province, L27

Other trials in Peru

About this study

Official title: A Phase II Prospective, Randomized, Multi-Center, Diabetic Macular Edema Dose Ranging, Comparator Study Evaluating The Efficacy And Safety Of PF-04523655 Versus Laser Therapy (DEGAS)

To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema

Read the detailed description

DEGAS termination decision date was December 17, 2010. Rationale: the objectives of the study could no longer be achieved. The study was not terminated for safety.

Being tested
Laser Treatment, PF-04523655 high, PF-04523655 middle, PF-04523655 low
Keywords
Phase II, Prospective, Randomized, Diabetic Macular Edema, PF-04523655, Laser
Medical subject headings
Diabetic Retinopathy, Diabetes Complications

What participants receive

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

  • Laser TreatmentProcedure or surgery

    Necessity of laser treatment is assessed every three months.

  • PF-04523655 highDrug

    3 mg intravitreal injection

  • PF-04523655 middleDrug

    1 mg intravitreal injection

  • PF-04523655 lowDrug

    0.4 mg intravitreal injection

Study groups in NCT00701181
Study groupRoleWhat they receive
LaserActive comparatorThis is a procedure - not a drug intervention.
Receives: Procedure: Laser Treatment
PF-04523655 (High)ExperimentalNot described
Receives: Drug: PF-04523655 high
PF-04523655 middleExperimentalNot described
Receives: Drug: PF-04523655 middle
PF-04523655 lowExperimentalNot described
Receives: Drug: PF-04523655 low

What is being measured

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

  1. Mean Change from Baseline in the Best Corrected Visual Acuity Score

    Measured: Month 24

Secondary outcomes (9)

  1. Mean Changes in NEI-VFQ-25 Composite Score from Baseline

    Measured: Month 24, 36

  2. Plasma Concentration of PF-04523655

    Measured: Week 1

  3. Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline.

    Measured: Month 24, 36

  4. Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination

    Measured: Month 24, 36

  5. Mean Change from Baseline in the Best Corrected Visual Acuity Score

    Measured: Month 36

  6. Mean Changes in Area of Fluorescein Leakage from Baseline

    Measured: Month 24, 36

  7. Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline.

    Measured: Month 24, 36

  8. Mean Changes in Retinal Thickness from Baseline

    Measured: Month 24, 36

  9. Mean Changes in Macular Volume from Baseline

    Measured: Month 24, 36

Timeline

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

  1. First posted19 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2011
  4. Study completionJan 2011

Why it stopped: See termination reason in detailed description.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00701181
Sponsor's protocol ID
B0451004
Acronym
DEGAS
Status last verified
Oct 2012
First submitted
17 Jun 2008
Last updated
11 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Nguyen QD, Schachar RA, Nduaka CI, Sperling M, Basile AS, Klamerus KJ, Chi-Burris K, Yan E, Paggiarino DA, Rosenblatt I, Aitchison R, Erlich SS; DEGAS Clinical Study Group. Dose-ranging evaluation of intravitreal siRNA PF-04523655 for diabetic macular edema (the DEGAS study). Invest Ophthalmol Vis Sci. 2012 Nov 15;53(12):7666-74. doi: 10.1167/iovs.12-9961.

    PubMed 23074206

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laser Treatment, PF-04523655 high and PF-04523655 middle in people with Diabetic Retinopathy and Diabetes Complications, run by Quark Pharmaceuticals at 53 sites in 8 countries.

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 2 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: stopped early, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Italy, United Kingdom, Israel, India and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.

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?

Mean Change from Baseline in the Best Corrected Visual Acuity Score (time frame: Month 24). 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 NCT00701181, 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 11 Oct 2012.

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