Macular EdemaPhase 3NCT01100307
A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema
A Phase 3 study testing pegaptanib sodium in people with Macular Edema and Diabetic Mellitus, run by Pfizer at 43 sites in Japan.
Trial summary
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Macular Edema, Diabetic Mellitus, Retinal Disease
- What is being tested?
- pegaptanib sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 43 sitesJapan
- Study dates
- May 2010to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type I, or Type II diabetic subjects
- Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive
Who cannot join
- Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months
- HbA1C level >12% or recent signs of uncontrolled diabetes
- Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Japan43 sites
Akita University Hospital
Akita, Akita
Hyogo Prefectural Amagasaki Hospital
Amagasaki, Hyōgo
Aomori Prefectural Chuo Hospital
Aomori, Aomori
Asahikawa Medical College Hospital
Asahikawa, Hokkaido
Chiba University Hospital
Chiba, Chiba
Nihon University Surugadai Hospital
Chiyoda-ku, Tokyo
Ochanomizu Inoue Eye Clinic
Chiyoda-ku, Tokyo
Hayashi Eye Hospital
Fukuoka, Fukuoka
Kyushu University Hospital
Fukuoka, Fukuoka
Murakami Karindo Hospital
Fukuoka, Fukuoka
Ohshima Hospital of Ophthalmology
Fukuoka, Fukuoka
Fukushima Medical University Hospital
Fukushima, Fukushima
Yoshida Eye Hospital
Hakodate, Hokkaido
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka
Hitachi General Hospital
Hitachi, Ibaraki
Kagoshima University Hospital
Kagoshima, Kagoshima-ken
Nara Medical University Hospital
Kashihara, Nara
Kagawa University Hospital
Kida-gun, Kagawa-ken
Kobe City Medical Center General Hospital
Kobe, Hyōgo
Kohnan Hospital
Kobe, Hyōgo
Ideta eye hospital
Kumamoto, Kumamoto
Kimura Eye & Internal Medicine Hospital
Kure, Hiroshima
St. Mary's Hospital
Kurume, Fukuoka
Kyoto University Hospital
Kyoto, Kyoto
Gunma University Hospital
Maebashi, Gunma
Shinshu University Hospital
Matsumoto, Nagano
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo
Mito Kyodo General Hospital
Mito, Ibaraki
Nagoya City University Hospital
Nagoya, Aichi-ken
Nagoya University Hospital
Nagoya, Aichi-ken
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken
Niigata University Medical and Dental Hospital
Niigata, Niigata
Osaka City University Hospital
Osaka, Osaka
Osaka general medical center
Osaka, Osaka
Osaka Saiseikai Izou Hospital
Osaka, Osaka
Kinki University Hospital, Anesthesiology
Osaka-sayama-shi, Osaka
Shiga University of Medical Science Hospital
Ōtsu, Shiga
Saga Prefectural Hospital Koseikan
Saga, Saga-ken
Hokkaido University Hospital
Sapporo, Hokkaido
NTT East Tohoku Hospital
Sendai, Miyagi
Keio University Hospital
Shinjuku-ku, Tokyo
Hirota Eye Clinic
Shūnan, Yamaguchi
Juntendo University Hospital Urayasu, Ophthalmology
Urayasu-shi, Chiba
About this study
Official title: A Phase 3, Randomized, Controlled, Double-Masked, Multi-Center, Comparative, In Parallel Groups (For 24 Weeks), To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium, With Sham Injections, And Open Study (For 30 Weeks) To Confirm The Safety Of 0.3 MG Pegaptanib Sodium In Subjects With Diabetic Macular Edema (DME)
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.
Read the detailed description
During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)
- Conditions
- Macular Edema, Diabetic Mellitus, Retinal Disease
- Being tested
- pegaptanib sodium, sham injection
- Keywords
- diabetic macular edema, Macugen, sham-controlled study
- Medical subject headings
- Macular Edema, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegaptanib sodiumDrug
Intravitreal injection of 0.3 mg every 6 weeks
sham injectionOther
sham injection every 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| pegaptanib sodium | Experimental | Not described Receives: Drug: pegaptanib sodium |
| sham injection | Sham comparator | Not described Receives: Other: sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Measured: Baseline and Week 24
Secondary outcomes (5)
Change From Baseline in Visual Acuity (VA): Double Masked Phase
Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts
Measured: Baseline, Weeks 6, 12, 18, and 24
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase
Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.
Measured: Up to 24 weeks
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Measured: Baseline and Week 54
Change From Baseline in Visual Acuity (VA): Open Phase
Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Measured: Baseline, Weeks 30, 36, 42, 48 and 54
Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase
Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.
Measured: Weeks 24 to 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100307
- Sponsor's protocol ID
- A5751034
- Status last verified
- May 2013
- First submitted
- 7 Apr 2010
- Last updated
- 23 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Controlled, Double-Masked, Multi-Center, Comparative, In Parallel Groups (For 24 Weeks), To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium, With Sham Injections, And Open Study (For 30 Weeks) To Confirm The Safety Of 0.3 MG Pegaptanib Sodium In Subjects With Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT01100307
- Acronym / sponsor ID
- A5751034
- Conditions
- Macular Edema, Diabetic Mellitus, Retinal Disease
- Keywords
- diabetic macular edema, Macugen, sham-controlled study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Apr 2010 (estimated)
- Results
- Posted 15 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.
Detailed description
During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pegaptanib sodium | Experimental | Drug: pegaptanib sodium |
| sham injection | Sham comparator | Other: sham injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type I, or Type II diabetic subjects
- Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive
Key exclusion criteria (3 listed)
- Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months
- HbA1C level >12% or recent signs of uncontrolled diabetes
- Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegaptanib sodiumIntravitreal injection of 0.3 mg every 6 weeks | Drug | pegaptanib sodium |
| sham injectionsham injection every 6 weeks | Other | sham injection |
Primary outcome
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase
Time frame: Baseline and Week 24
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
5 secondary outcomes
Change From Baseline in Visual Acuity (VA): Double Masked Phase
Time frame: Baseline, Weeks 6, 12, 18, and 24
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase
Time frame: Up to 24 weeks
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase
Time frame: Baseline and Week 54
Change From Baseline in Visual Acuity (VA): Open Phase
Time frame: Baseline, Weeks 30, 36, 42, 48 and 54
Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase
Time frame: Weeks 24 to 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pegaptanib sodium in people with Macular Edema and Diabetic Mellitus, run by Pfizer at 43 sites in Japan.
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 2 inclusion and 3 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 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Japan. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2013.