Macular Edema Associated With Diabetes Mellitus Clinical Trial
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.
| Verified date | October 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 317 |
| Est. completion date | July 2011 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - macular edema associated with diabetes - visual acuity between 20/50 and 20/200 Exclusion Criteria: - recent laser therapy in the eye - recent signs of uncontrolled diabetes - blood pressure worse than 160/100 - severe cardiac disease |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | East Melbourne | |
| Australia | Pfizer Investigational Site | Westmead | New South Wales |
| Austria | Pfizer Investigational Site | Innsbruck | |
| Austria | Pfizer Investigational Site | Wien | |
| Brazil | Pfizer Investigational Site | Gioania | GO |
| Brazil | Pfizer Investigational Site | Porto Alegre | |
| Brazil | Pfizer Investigational Site | Sao Paolo | |
| Brazil | Pfizer Investigational Site | Sao Paulo | |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Colombia | Pfizer Investigational Site | Bogota | |
| Czechia | Pfizer Investigational Site | Brno | |
| Czechia | Pfizer Investigational Site | Hradec Kralove | |
| Czechia | Pfizer Investigational Site | Olomouc | |
| Czechia | Pfizer Investigational Site | Praha 4 | |
| Czechia | Pfizer Investigational Site | Praha 6 | |
| Denmark | Pfizer Investigational Site | Glostrup | |
| France | Pfizer Investigational Site | Clermont | |
| France | Pfizer Investigational Site | Creteil | Cedex |
| France | Pfizer Investigational Site | Lyon | |
| France | Pfizer Investigational Site | Marseille | |
| France | Pfizer Investigational Site | Marseille Cedex 5 | |
| France | Pfizer Investigational Site | Marsielle | |
| France | Pfizer Investigational Site | Nancy Cedex | |
| France | Pfizer Investigational Site | Paris Cedex 12 | |
| Germany | Pfizer Investigational Site | Bonn | |
| Germany | Pfizer Investigational Site | Duesseldorf | |
| Germany | Pfizer Investigational Site | Heidelberg | |
| Germany | Pfizer Investigational Site | Leipzig | |
| Germany | Pfizer Investigational Site | Muenster | |
| Germany | Pfizer Investigational Site | Tuebingen | |
| Greece | Pfizer Investigational Site | Athens | |
| India | Pfizer Investigational Site | Ahmedabad | |
| India | Pfizer Investigational Site | Bangalore | |
| India | Pfizer Investigational Site | Hyderabad | |
| India | Pfizer Investigational Site | New Delhi | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Udine | |
| Netherlands | Pfizer Investigational Site | Nijmegen | |
| Portugal | Pfizer Investigational Site | Coimbra | |
| South Africa | Pfizer Investigational Site | Bloemfontein | |
| Switzerland | Pfizer Investigational Site | Bern | |
| United Kingdom | Pfizer Investigational Site | Newcastle Upon Tyne | |
| United Kingdom | Pfizer Investigational Site | Sheffield | |
| United States | Pfizer Investigational Site | 'Aiea | Hawaii |
| United States | Pfizer Investigational Site | Abilene | Texas |
| United States | Pfizer Investigational Site | Augusta | Georgia |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Fort Lauderdale | Florida |
| United States | Pfizer Investigational Site | Fort Worth | Texas |
| United States | Pfizer Investigational Site | Hamden | Connecticut |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Lynbrook | New York |
| United States | Pfizer Investigational Site | McAllen | Texas |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Oakland | California |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Pittsburgh | Pennsylvania |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Santa Ana | California |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Temple | Texas |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | West Columbia | South Carolina |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Austria, Brazil, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, India, Italy, Netherlands, Portugal, South Africa, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Baseline, Year 1 | |
| Secondary | 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 | Baseline, Year 2 | |
| Secondary | 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 | Baseline, Year 1 | |
| Secondary | 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 | Baseline, Year 2 | |
| Secondary | 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. | Baseline, Year 1 | |
| Secondary | 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. | Baseline, Year 1 | |
| Secondary | 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. | Baseline, Year 2 | |
| Secondary | 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. | Baseline, Year 2 | |
| Secondary | 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. | Baseline, Year 1 | |
| Secondary | 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. | Baseline, Year 2 | |
| Secondary | 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 | 1 year | |
| Secondary | 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 | 2 years |