AzTrials
AzTrials

Choroidal NeovascularizationPhase 2MATISSENCT01445899

PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)

A Phase 2 study testing PF-04523655 (Stratum I), ranibizumab and PF-04523655 (Stratum II) in people with Choroidal Neovascularization and Diabetic Retinopathy, run by Quark Pharmaceuticals at 51 sites in 7 countries.

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

This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patients who participate. Stratum I will determine the maximum tolerated dose and any dose-limiting toxicities. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-04523655 (Stratum I), ranibizumab and PF-04523655 (Stratum II)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
51 sitesin 7 countries
Study dates
Feb 2012to Nov 2013
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

Key Stratum I Inclusion Criteria:

  1. Visual acuity in the study eye ≤ 20/200.
  2. Low visual acuity is the result of an irreversible condition affecting the posterior segment of the study eye.

Key Stratum I Exclusion Criteria:

  1. History of vitrectomy.
  2. History of IVT injection in study eye within last 6 months.
  3. History of vitreous hemorrhage, retinal detachment, or invasive trauma in study eye.
  4. History of uveitis or endophthalmitis in either eye.
  5. Any active inflammatory condition in study eye.
  6. Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
  7. Any medical condition, concomitant therapy or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye.
  8. Intraocular pressure in either eye ≥25 mmHg on maximal medication.
  9. Cataract surgery and laser corneal surgery within 3 months prior to dosing in the study eye and all other intraocular surgeries at any time.
  10. Participation in a concurrent interventional study within 30 days prior to dosing.

Key Stratum II Inclusion Criteria:

  1. History of diabetes mellitus (Type 1 or Type 2).
  2. Retinal thickening secondary to the edema caused by diabetes mellitus.
  3. Best corrected visual acuity (BCVA) of 20/40 or worse and up to 20/320 or better in the study eye at Screening.
  4. Standard of care treatment for DME can be withheld for at least 90 days after the subject has enrolled in the study (study eye only).

Key Stratum II Exclusion Criteria:

  1. History of panretinal photocoagulation within 6 months or macular laser photocoagulation within 3 months of prior to dosing in the study eye.
  2. Any IVT injection therapy performed in the study eye within 3 months prior to dosing.
  3. Iris neovascularization, vitreous hemorrhage, tractional retinal detachment, vitreomacular traction, clinically significant epiretinal membrane or clinically significant preretinal fibrosis involving the macula in the study eye.
  4. History of vitreoretinal surgery or incisional glaucoma surgery in the study eye.
  5. Prior intraocular surgery or corneal laser surgery, performed within 3 months prior to dosing in the study eye.
  6. Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
  7. High risk (in the opinion of the Investigator) proliferative diabetic retinopathy (PDR) in the study eye.
  8. Current infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
  9. Monocular subjects.
  10. History of idiopathic or autoimmune uveitis in either eye.
  11. Aphakia or absence of the posterior capsule in the study eye.
  12. Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
  13. Uncontrolled glaucoma in either eye.
  14. Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia.
  15. Use of corticosteroids that, in the Investigator's opinion, may change the status of the subject's diabetic retinopathy in the study eye.

Trial locations and contacts

51 sites in 7 countries.

51 sites in 7 countries

United States20 sites

  • Retina Institute of California

    Arcadia, California, 91007

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Retina Research Center

    Austin, Texas, 78705

  • Retina-Vitreous Associates

    Beverly Hills, California, 90211

  • Retina Diagnostic Center

    Campbell, California, 95008

  • Southeast Clinical Research Associates, LLC

    Charlotte, North Carolina, 28210

  • Retinal Consultants of Houston

    Houston, Texas, 77030

  • Thomas A. Cuilla, MD, PC at Midwest Eye Institute

    Indianapolis, Indiana, 46290

  • Valley Retina Institute

    McAllen, Texas, 78503

  • MedEye Associates

    Miami, Florida, 33143

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

  • Retina Consultants of Arizona

    Phoenix, Arizona, 85014

  • Eyesight Ophthalmic Services, PA

    Portsmouth, New Hampshire, 03801

  • Black Hills Regioinal Eye Institute

    Rapid City, South Dakota, 57701

  • Retinal Institute of Virginia

    Richmond, Virginia, 23235

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95819

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78204

  • Orange County Reina Medical Group

    Santa Ana, California, 92705

  • Retina Vitreous Center

    Toms River, New Jersey, 08755

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

Israel9 sites

  • Soroka University Medical Center

    Beersheba, Israel, 84101

  • Bnai Zion Medical Center

    Haifa, Israel, 31048

  • Hadassah Ein Kerem Medical Center

    Jerusalem

  • Meir Medical Center

    Kfar Saba, Israel, 44281

  • Rabin Medical Center

    Petah Tikva

  • Kaplan Medical Center

    Rehovot

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

  • The Chaim Sheba Medical Center

    Tel HaShomer, Israel, 52621

  • Assaf Harofe Medical Center

    Tsrifin

Other trials in Israel

United Kingdom7 sites

  • Eye and Ear Clinicl, The Royal Victoria Hospital

    Belfast, United Kingdom, BT12 6BA

  • Bristol Eye Hospital

    Bristol, United Kingdom, BS1 2LX

  • Frimley Park Hospital NHS Foundation Trust

    Frimley, Surrey, GU16 7UJ

  • St. James University Hospital

    Leeds, United Kingdom, LS9 7TF

  • Moorfields Eye Hospital

    London, United Kingdom, EC1V 2PD

  • Royal Hallamshire Hospital, Eye Department

    Sheffield, United Kingdom, S10 2JF

  • Southamptom Eye Unit, Southampton Hospital

    Shirley, Southampton, SO16 6YD

Other trials in United Kingdom

Germany5 sites

  • Augenärzte Gemeinschaftspraxis Ahaus-Gronau-Lingen-Münster-Bad Bentheim

    Ahaus, Germany, 48683

  • Augenklinik Klinikum Darmstadt

    Darmstadt, Germany, 64297

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, Germany, 67063

  • Klinik und Poliklinik für Augenheilkunde Klinikum rechts der Isar

    München, Germany, 81675

  • Augenklinik am St. Franziskus-Hospital Muenster

    Münster, Germany, 48145

Other trials in Germany

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, Czech Republic, 62500

  • Fakultní nemocnice Hradec Kralove

    Kralove, Czech Republic, 50005

  • Fakultní nemocnice Ostrava

    Ostrava, Czech Republic, 70852

  • GEMINI oční centrum, a.s

    Zlín, Czech Republic, 76001

Other trials in Czechia

Poland4 sites

  • Oftalmika

    Bydgoszcz, Poland, 85631

  • Szpital Specjalistyczny Nr 1 w Bytomiu

    Bytom, Poland, 41902

  • Profesorskie Centrum Okulistyki, Hipermarket Tesco

    Gdansk, Poland, 80809

  • Spectrum OOK

    Wroclaw, Poland, 51-646

Other trials in Poland

Belgium2 sites

  • University Hospital Ghent

    Ghent, Belgium, 9000

  • Brugmann Ziekenhuis

    Laken, Belgium, 1020

Other trials in Belgium

About this study

Official title: An Open-Label Dose Escalation Study of PF-04523655 (Stratum I) Combined With a Prospective, Randomized, Double-Masked, Multi-Center, Controlled Study (Stratum II) Evaluating the Efficacy and Safety of PF-04523655 Alone and in Combination With Ranibizumab Versus Ranibizumab Alone in Diabetic Macular Edema (MATISSE STUDY)

This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patients who participate. Stratum I will determine the maximum tolerated dose and any dose-limiting toxicities. The second part (Stratum II) is a prospectively randomized, multi-center, double-masked, dose ranging study evaluating the efficacy and safety of PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in patients with DME.

Read the detailed description

Patients will be enrolled concurrently according to one of two sets of criteria designated as Stratum I and Stratum II.

  1. Stratum I will enroll up to 24 subjects with low vision, inclusive of possible intermediate doses, in up to 4 cohorts of 3-6 evaluable subjects.
  2. Stratum II will enroll approximately 240 subjects with DME 1:1:1:1 in up to 4 cohorts of 60 evaluable subjects.
Being tested
PF-04523655 (Stratum I), ranibizumab, PF-04523655 (Stratum II)
Medical subject headings
Choroidal Neovascularization, Diabetic Retinopathy

What participants receive

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

  • PF-04523655 (Stratum I)Drug

    Also called PF-655

    PF-04523655 (a small interfering RNA) - a single IVT injection

  • ranibizumabDrug

    Also called Lucentis

    6 monthly IVT injections of ranibizumab (Stratum II)

  • PF-04523655 (Stratum II)Drug

    Also called PF-655

    6 monthly IVT injections of PF-04523655 (a small interfering RNA)

Study groups in NCT01445899
Study groupRoleWhat they receive
PF-04523655 (Stratum II)ExperimentalStratum II, 6 monthly injections of PF-04523655 only
Receives: Drug: PF-04523655 (Stratum II)
PF-04523655 and ranibizumabExperimentalStratum II, 6 monthly injections of PF-0423655 and ranibizumab administered in combination
Receives: Drug: ranibizumab; Drug: PF-04523655 (Stratum II)
ranibizumabActive comparatorStratum II, 6 monthly IVT injections of ranibizumab only
Receives: Drug: ranibizumab
PF-04523655 (Stratum I)ExperimentalStratum I
Receives: Drug: PF-04523655 (Stratum I)

What is being measured

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

  1. Safety and dose-limiting toxicities (Stratum I)

    • To determine the safety and dose-limiting toxicities of a single intravitreal (IVT) injection of PF-04523655 in subjects with low vision

    Measured: 6 months post-injection

  2. Pharmacokinetics (Stratum I)

    • To determine the pharmacokinetics (PK) of a single IVT injection of PF-04523655 in subjects with low vision

    Measured: 6 months post-injection

  3. Safety and tolerability (Stratum II)

    • To evaluate the safety and tolerability of PF-04523655 alone and in combination with ranibizumab in subjects with diabetic macular edema (DME)

    Measured: 30 days after the last injection

  4. Efficacy (Stratum II)

    • To evaluate the ability of PF-04523655 alone and in combination with ranibizumab to improve visual acuity compared to ranibizumab alone in subjects with DME

    Measured: 30 days after the last injection

Secondary outcomes (1)

  1. Anatomical changes in retina and retinal nerve fiber layer morphology (Stratum II)

    • To evaluate the anatomical changes in retina and retinal nerve fiber layer (RNFL) morphology following administration of PF-04523655 alone and in combination with ranibizumab compared to ranibizumab alone by fundus photography (FP) and spectral domain optical coherence tomography (SD-OCT)

    Measured: 30 days after the last injection

Timeline

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

  1. First posted4 Oct 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01445899
Sponsor's protocol ID
QRK202
Other IDs
2011-004157-66
Acronym
MATISSE
Status last verified
Feb 2015
First submitted
30 Sep 2011
Last updated
23 Feb 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04523655 (Stratum I), ranibizumab and PF-04523655 (Stratum II) in people with Choroidal Neovascularization and Diabetic Retinopathy, run by Quark Pharmaceuticals at 51 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Israel, United Kingdom, Germany, Czechia and 2 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 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?

Safety and dose-limiting toxicities (Stratum I) (time frame: 6 months post-injection). The study lists 4 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 NCT01445899.

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 23 Feb 2015.

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