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See termination reason in detailed description.
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The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet age-related macular degeneration (AMD) in Indian patients.Prospective, Observational, Non-interventional Study. The period of observation for the study will be 1 year
To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD). The decision to prescribe Macugen will necessarily precede and will be independent of the decision to enroll patient into the study.
If both eyes of a patient receive injection Macugen, only one eye will be included in the study. If both eyes receive first injection Macugen after initiation of the study, only the first treated eye will be included in the analysis. If one eye has already received Macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis.
The study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on August 30, 2010. There were no safety concerns regarding the study in the decision to terminate the trial.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA) | VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA. | Baseline through 12 months or last follow-up visit before study termination |
| Average Number of Injections to Achieve Stabilization of VA | Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up. | 12 months or last follow-up visit before study termination |
| Median Number of Injections to Achieve Stabilization of VA | Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up. | 12 months or last follow-up visit before study termination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy | Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study. |
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Inclusion Criteria:
Exclusion Criteria:
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To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Navrangpura, Ahemdabad | Gujarat | 380009 | India | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegaptanib | Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegaptanib | Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA) | VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA. | Full Analysis Set (FAS) included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by Last Observation Carried Forward (LOCF) technique. | Posted | Number | percentage of participants | Baseline through 12 months or last follow-up visit before study termination |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pegaptanib | Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal haemorrhage | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
Outcome measures were not designated as primary or secondary measures as this study was an observational non-interventional study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| 12 months or last follow-up visit before study termination |
| Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters | OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). | 12 months or last follow-up visit before study termination |
| Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters | A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions. | 12 months or last follow-up visit before study termination |
| Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA | Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA. | 12 months or last follow-up visit before study termination |
| Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions | Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up. | 12 months or last follow-up visit before study termination |
| Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions | Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up. | 12 months or last follow-up visit before study termination |
| Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA | FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA. | 12 months or last follow-up visit before study termination |
| Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen | Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen. | 12 months or last follow-up visit before study termination |
| Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy | VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient's VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA. | 12 months or last follow-up visit before study termination |
| Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy | OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter. | 12 months or last follow-up visit before study termination |
| Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive | OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter. | 12 months or last follow-up visit before study termination |
| Gurgaon |
| Haryana |
| 122 002 |
| India |
| Pfizer Investigational Site | Kochi | Kerala | 682 015 | India |
| Pfizer Investigational Site | Mumbai | Maharashtra | 400 054 | India |
| Pfizer Investigational Site | Jaipur | Rajasthan | 302 004 | India |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pegaptanib |
Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye. |
|
|
| Primary | Average Number of Injections to Achieve Stabilization of VA | Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up. | FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up. | Posted | Mean | Standard Deviation | injections | 12 months or last follow-up visit before study termination |
|
|
|
| Primary | Median Number of Injections to Achieve Stabilization of VA | Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up. | FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up. | Posted | Median | Full Range | injections | 12 months or last follow-up visit before study termination |
|
|
|
| Secondary | Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy | Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study. | FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF analysis. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
|
| Secondary | Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters | OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). | FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
|
| Secondary | Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters | A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions. | Due to small sample size, the analysis was not conducted. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
| Secondary | Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA | Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA. | Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
| Secondary | Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions | Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up. | Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment. | Posted | Number | injections | 12 months or last follow-up visit before study termination |
|
|
| Secondary | Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions | Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up. | Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment. | Posted | Median | Full Range | injections | 12 months or last follow-up visit before study termination |
|
|
| Secondary | Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA | FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA. | Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
| Secondary | Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen | Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen. | Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
| Secondary | Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy | VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient's VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA. | Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
| Secondary | Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy | OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter. | Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
| Secondary | Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive | OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter. | Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment. | Posted | Number | Percentage of participants | 12 months or last follow-up visit before study termination |
|
|
| 0 |
| 22 |
| 3 |
| 22 |
| Visual acuity reduced | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Subretinal fibrosis | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| No 'center subfield' value |
|