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
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01100307
First received: April 7, 2010
Last updated: April 25, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Edema Diabetic Mellitus Retinal Disease |
Drug: pegaptanib sodium Other: sham injection |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
Drug Information available for:
Pegaptanib sodium
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The proportion of subjects who experience a ≥ 10 letter improvement of visual acuity in ETDRS chart from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean change of VA over time [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects underwent focal or grid laser [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects underwent vitrectomy [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- Mean VA over time and distribution of mean VA at each time point [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects who experience a ≥ 10 letter improvement of visual acuity in ETDRS chart from baseline over time [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects who experience a ≥ 15 letter improvement of visual acuity in ETDRS chart from baseline [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects who experience a ≥ 5 letter improvement of visual acuity in ETDRS chart from baseline [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects who experience a ≥ 0 letter improvement of visual acuity in ETDRS chart from baseline [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- The proportion of subjects exhibiting a decrease in retinal thickness at the center point by 25% and 50% using OCT [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- The mean change in NEI-VFQ 25 scores from baseline [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
- Adverse Events, Serious Adverse Events, Laboratory events [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 243 |
| Study Start Date: | May 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: pegaptanib sodium |
Drug: pegaptanib sodium
Intravitreal injection of 0.3 mg every 6 weeks
|
| Sham Comparator: sham injection |
Other: sham injection
sham injection every 6 weeks
|
Detailed Description:
During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100307
Locations
| Japan | |
| National Hospital Organization Nagoya Medical Center | |
| Nagoya, Aichi, Japan | |
| Nagoya University Hospital | |
| Nagoya, Aichi, Japan | |
| Nagoya City University Hospital | |
| Nagoya, Aichi, Japan | |
| Juntendo University Hospital Urayasu, Ophthalmology | |
| Urayasu-shi, Chiba-Ken, Japan | |
| St. Mary's Hospital | |
| Kurume, Fukuoka, Japan | |
| Gunma University Hospital | |
| Maebashi, Gumma, Japan | |
| Kimura Eye & Internal Medicine Hospital | |
| Kure, Hiroshima, Japan | |
| Asahikawa Medical College Hospital | |
| Asahikawa, Hokkaido, Japan | |
| Yoshida Eye Hospital | |
| Hakodate, Hokkaido, Japan | |
| Hokkaido University Hospital | |
| Sapporo, Hokkaido, Japan | |
| Hyogo Prefectural Amagasaki Hospital | |
| Amagasaki, Hyogo, Japan | |
| Kohnan Hospital | |
| Kobe, Hyogo, Japan | |
| Kobe City Medical Center General Hospital | |
| Kobe, Hyogo, Japan | |
| Hitachi General Hospital | |
| Hitachi, Ibaraki, Japan | |
| Mito Kyodo General Hospital | |
| Mito, Ibaraki, Japan | |
| Kagawa University Hospital | |
| Kida-gun, Kagawa, Japan | |
| NTT East Tohoku Hospital | |
| Sendai, Miyagi, Japan | |
| Shinshu University Hospital | |
| Matsumoto, Nagano, Japan | |
| Nara Medical University Hospital | |
| Kashihara, Nara, Japan | |
| Kinki University Hospital, Anesthesiology | |
| Osaka-sayama-shi, Osaka, Japan | |
| Shiga University of Medical Science Hospital | |
| Otsu, Shiga, Japan | |
| Seirei Hamamatsu General Hospital | |
| Hamamatsu, Shizuoka, Japan | |
| Ochanomizu Inoue Eye Clinic | |
| Chiyoda-ku, Tokyo, Japan | |
| Nihon University Surugadai Hospital | |
| Chiyoda-ku, Tokyo, Japan | |
| National Hospital Organization Tokyo Medical Center | |
| Meguro-ku, Tokyo, Japan | |
| Keio University Hospital | |
| Shinjuku-ku, Tokyo, Japan | |
| Hirota Eye Clinic | |
| Shunan, Yamaguchi, Japan | |
| Akita University Hospital | |
| Akita, Japan | |
| Aomori Prefectural Chuo Hospital | |
| Aomori, Japan | |
| Chiba University Hospital | |
| Chiba, Japan | |
| Kyushu University Hospital | |
| Fukuoka, Japan | |
| Murakami Karindo Hospital | |
| Fukuoka, Japan | |
| Hayashi Eye Hospital | |
| Fukuoka, Japan | |
| Ohshima Hospital of Ophthalmology | |
| Fukuoka, Japan | |
| Fukushima Medical University Hospital | |
| Fukushima, Japan | |
| Kagoshima University Hospital | |
| Kagoshima, Japan | |
| Ideta eye hospital | |
| Kumamoto, Japan | |
| Kyoto University Hospital | |
| Kyoto, Japan | |
| Niigata University Medical and Dental Hospital | |
| Niigata, Japan | |
| Osaka Saiseikai Izou Hospital | |
| Osaka, Japan | |
| Osaka general medical center | |
| Osaka, Japan | |
| Osaka City University Hospital | |
| Osaka, Japan | |
| Saga Prefectural Hospital Koseikan | |
| Saga, Japan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01100307 History of Changes |
| Other Study ID Numbers: | A5751034 |
| Study First Received: | April 7, 2010 |
| Last Updated: | April 25, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Pfizer:
|
diabetic macular edema Macugen sham-controlled study |
Additional relevant MeSH terms:
|
Edema Macular Edema Retinal Diseases Signs and Symptoms |
Macular Degeneration Retinal Degeneration Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013