Macular Edema Associated With Diabetes MellitusPhase 2/3NCT00605280
A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.
A Phase 2/3 study testing Macugen in people with Macular Edema Associated With Diabetes Mellitus, run by Pfizer at 73 sites in 18 countries.
Trial summary
The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema Associated With Diabetes Mellitus
- What is being tested?
- Macugen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 73 sitesin 18 countries
- Study dates
- Sep 2005to Jul 2011
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- macular edema associated with diabetes
- visual acuity between 20/50 and 20/200
Who cannot join
- recent laser therapy in the eye
- recent signs of uncontrolled diabetes
- blood pressure worse than 160/100
- severe cardiac disease
Trial locations and contacts
73 sites in 18 countries.
73 sites in 18 countries
United States28 sites
Pfizer Investigational Site
‘Aiea, Hawaii, 96701
Pfizer Investigational Site
Abilene, Texas, 79606
Pfizer Investigational Site
Augusta, Georgia, 30909
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Denver, Colorado, 80230
Pfizer Investigational Site
Detroit, Michigan, 48201-1423
Pfizer Investigational Site
Fort Lauderdale, Florida, 33334-4146
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Hamden, Connecticut, 06518
Pfizer Investigational Site
Houston, Texas, 77002
Pfizer Investigational Site
Indianapolis, Indiana, 46280
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Lynbrook, New York, 11563
Pfizer Investigational Site
McAllen, Texas, 78503
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Oakland, California, 94609
Pfizer Investigational Site
Phoenix, Arizona, 85020
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
Santa Ana, California, 92705
Pfizer Investigational Site
Tampa, Florida, 33609
Pfizer Investigational Site
Tampa, Florida, 33612
Pfizer Investigational Site
Temple, Texas, 76508
Pfizer Investigational Site
Tucson, Arizona, 85704
Pfizer Investigational Site
West Columbia, South Carolina, 29169
Pfizer Investigational Site
Wichita, Kansas, 67214
France8 sites
Pfizer Investigational Site
Clermont, 63003
Pfizer Investigational Site
Créteil, Cedex, 94010
Pfizer Investigational Site
Lyon, 69006
Pfizer Investigational Site
Marseille, 13008
Pfizer Investigational Site
Marseille, 13385
Pfizer Investigational Site
Marsielle, 13008
Pfizer Investigational Site
Nancy, 54035
Pfizer Investigational Site
Paris, 75571
Germany6 sites
Pfizer Investigational Site
Bonn, 53105
Pfizer Investigational Site
Düsseldorf, 40225
Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Münster, 48145
Pfizer Investigational Site
Tübingen, 72706
Czechia5 sites
Pfizer Investigational Site
Brno, 625 00
Pfizer Investigational Site
Hradec Králové, 50005
Pfizer Investigational Site
Olomouc, 775 20
Pfizer Investigational Site
Prague, 140 00
Pfizer Investigational Site
Prague, 169 00
Brazil4 sites
Pfizer Investigational Site
Gioania, Goiás, 74210-010
Pfizer Investigational Site
Porto Alegre, 90035-003
Pfizer Investigational Site
São Paulo, 04524-020
Pfizer Investigational Site
São Paulo, SP 04524-20
India4 sites
Pfizer Investigational Site
Ahmedabad, 380 004
Pfizer Investigational Site
Bangalore, 560 085
Pfizer Investigational Site
Hyderabad, 500 034
Pfizer Investigational Site
New Delhi, 110 029
Italy3 sites
Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Milan, 20132
Pfizer Investigational Site
Udine, 33100
Australia2 sites
Pfizer Investigational Site
East Melbourne
Pfizer Investigational Site
Westmead, New South Wales, 2145
Austria2 sites
Pfizer Investigational Site
Innsbruck, A-6020
Pfizer Investigational Site
Vienna, A-1180
Canada2 sites
Pfizer Investigational Site
Montreal, Quebec, H1T 2H1
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 3N9
United Kingdom2 sites
Pfizer Investigational Site
Newcastle upon Tyne, NE1 4LP
Pfizer Investigational Site
Sheffield, S10 2JF
About this study
Official title: A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.
The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.
- Being tested
- Standard of Care, Macugen
- Keywords
- randomized sham-controlled multicenter macular edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareDrug
Clinicians decision to use optional laser therapy.
MacugenDrug
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Sham Control | Sham comparator | Not described Receives: Drug: Standard of Care |
| Macugen | Experimental | Not described Receives: Drug: Macugen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
Measured: Baseline, Year 1
Secondary outcomes (11)
Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Measured: Baseline, Year 2
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Measured: Baseline, Year 1
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Measured: Baseline, Year 2
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.
Measured: Baseline, Year 1
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.
Measured: Baseline, Year 1
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.
Measured: Baseline, Year 2
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.
Measured: Baseline, Year 2
Change From Baseline in Mean VA Score at 1 Year
Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.
Measured: Baseline, Year 1
Change From Baseline in Mean VA Score at 2 Years
Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.
Measured: Baseline, Year 2
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
Measured: 1 year
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionNov 2009
- Study completionJul 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular Edema Associated With Diabetes MellitusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 317 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
- NCT00605280
- Sponsor's protocol ID
- A5751013
- Other IDs
- EOP1013H
- Status last verified
- Oct 2018
- First submitted
- 18 Jan 2008
- Last updated
- 16 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Loftus JV, Sultan MB, Pleil AM; Macugen 1013 Study Group. Changes in vision- and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7498-505. doi: 10.1167/iovs.11-7613.
PubMed 21896838
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.
- ClinicalTrials.gov ID
- NCT00605280
- Acronym / sponsor ID
- A5751013
- Keywords
- randomized sham-controlled multicenter macular edema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 30 Mar 2011
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 is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Control | Sham comparator | Drug: Standard of Care |
| Macugen | Experimental | Drug: Macugen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- macular edema associated with diabetes
- visual acuity between 20/50 and 20/200
Key exclusion criteria (4 listed)
- recent laser therapy in the eye
- recent signs of uncontrolled diabetes
- blood pressure worse than 160/100
- severe cardiac disease
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 |
|---|---|---|
| Standard of CareClinicians decision to use optional laser therapy. | Drug | Sham Control |
| MacugenIntravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years. | Drug | Macugen |
Primary outcome
Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
Time frame: Baseline, Year 1
Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
11 secondary outcomes
Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Time frame: Baseline, Year 2
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Time frame: Baseline, Year 1
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Time frame: Baseline, Year 2
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
Time frame: Baseline, Year 1
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
Time frame: Baseline, Year 1
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
Time frame: Baseline, Year 2
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
Time frame: Baseline, Year 2
Change From Baseline in Mean VA Score at 1 Year
Time frame: Baseline, Year 1
Change From Baseline in Mean VA Score at 2 Years
Time frame: Baseline, Year 2
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
Time frame: 1 year
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21896838Loftus JV, Sultan MB, Pleil AM; Macugen 1013 Study Group. Changes in vision- and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7498-505. doi: 10.1167/iovs.11-7613.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Macular Edema Associated With Diabetes Mellitus
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
RecruitingObservational study
Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales
Diabetic Retinopathy (DR), Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus
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
73 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Macugen in people with Macular Edema Associated With Diabetes Mellitus, run by Pfizer at 73 sites in 18 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 2 inclusion and 4 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, France, Germany, Czechia, Brazil and 13 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. 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 combined 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.
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 30 Mar 2011). 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 With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year (time frame: Baseline, Year 1). 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 NCT00605280, 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 16 Nov 2018.