Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT00324116
Status:
COMPLETED
Last Update Posted:
2010-03-23
First Post:
2006-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C495058', 'term': 'pegaptanib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.', 'otherNumAffected': 28, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Myodesopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'classes': [{'title': 'Responders', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '95'}]}]}, {'title': 'Non-Responders', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Censored (subjects with missing data)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percent responders', 'ciPctValue': '95', 'paramValue': '85', 'ciLowerLimit': '76', 'ciUpperLimit': '95', 'estimateComment': 'Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 54 Weeks', 'description': 'Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'classes': [{'title': '6 weeks (n=76)', 'categories': [{'measurements': [{'value': '-4.29', 'spread': '11.11', 'groupId': 'OG000'}]}]}, {'title': '12 weeks (n=74)', 'categories': [{'measurements': [{'value': '-5.86', 'spread': '13.79', 'groupId': 'OG000'}]}]}, {'title': '54 weeks (n=49)', 'categories': [{'measurements': [{'value': '-11.12', 'spread': '17.96', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-4.29', 'ciLowerLimit': '-6.83', 'ciUpperLimit': '-1.75', 'estimateComment': '95% CI for the change in mean value obtained from one sample t-test.', 'groupDescription': '6 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-5.86', 'ciLowerLimit': '-9.06', 'ciUpperLimit': '-2.67', 'estimateComment': '95% CI for the change in mean value obtained from one sample t-test.', 'groupDescription': '12 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-11.12', 'ciLowerLimit': '-16.28', 'ciUpperLimit': '-5.96', 'estimateComment': '95% CI for the change in mean value obtained from one sample t-test.', 'groupDescription': '54 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 54 weeks', 'description': 'Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=number of subjects with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Gaining Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'classes': [{'title': 'Gained', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Did not gain', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Assessment Not Done', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percentage of subjects', 'ciPctValue': '95', 'paramValue': '5.00', 'ciLowerLimit': '1.61', 'ciUpperLimit': '11.32', 'estimateComment': 'Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '54 weeks or at early termination', 'description': 'Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Maintaining Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'classes': [{'title': 'Maintained', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Did not maintain', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Not Done', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percentage of subjects', 'ciPctValue': '95', 'paramValue': '22.50', 'ciLowerLimit': '14.22', 'ciUpperLimit': '32.11', 'estimateComment': 'Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '54 weeks or at early termination', 'description': 'Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Severe Visual Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'classes': [{'title': 'Severe Loss', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Not severe loss', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Not Done', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percentage of subjects', 'ciPctValue': '95', 'paramValue': '13.75', 'ciLowerLimit': '7.39', 'ciUpperLimit': '22.24', 'estimateComment': 'Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '54 weeks or at early termination', 'description': 'Subjects with severe visual loss: loss from baseline of \\>= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percentage of subjects', 'ciPctValue': '95', 'paramValue': '25.97', 'ciLowerLimit': '16.28', 'ciUpperLimit': '34.81', 'estimateComment': 'Proportion of subjects progressing to \\<=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '54 weeks', 'description': 'Subjects with improving scores are those with \\> 20/200 at Baseline and progressing to =\\< 20/200 at Week 54.\n\nSubjects with no change are those with \\> 20/200 at Baseline and remaining at \\> 20/200 at Week 54.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=77 (number of Subjects at Baseline with \\>20/200 Visual Acuity)'}, {'type': 'SECONDARY', 'title': 'Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'classes': [{'title': 'Composite (n=25)', 'categories': [{'measurements': [{'value': '-2.25', 'spread': '15.71', 'groupId': 'OG000'}]}]}, {'title': 'General Health (n=42)', 'categories': [{'measurements': [{'value': '-4.17', 'spread': '14.52', 'groupId': 'OG000'}]}]}, {'title': 'General Vision (n=41)', 'categories': [{'measurements': [{'value': '3.90', 'spread': '16.26', 'groupId': 'OG000'}]}]}, {'title': 'Ocular Pain (n=43)', 'categories': [{'measurements': [{'value': '0.35', 'spread': '15.29', 'groupId': 'OG000'}]}]}, {'title': 'Near Vision Activities (n=43)', 'categories': [{'measurements': [{'value': '-3.88', 'spread': '27.60', 'groupId': 'OG000'}]}]}, {'title': 'Distance Vision Activities (n=43)', 'categories': [{'measurements': [{'value': '-6.78', 'spread': '23.68', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning (n=43)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '24.84', 'groupId': 'OG000'}]}]}, {'title': 'Mental Health Activities (n=43)', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '20.45', 'groupId': 'OG000'}]}]}, {'title': 'Role Difficulties (n=41)', 'categories': [{'measurements': [{'value': '-4.39', 'spread': '26.46', 'groupId': 'OG000'}]}]}, {'title': 'Dependency (n=41)', 'categories': [{'measurements': [{'value': '-5.28', 'spread': '22.15', 'groupId': 'OG000'}]}]}, {'title': 'Driving (n=27)', 'categories': [{'measurements': [{'value': '-3.70', 'spread': '30.67', 'groupId': 'OG000'}]}]}, {'title': 'Color Vision (n=41)', 'categories': [{'measurements': [{'value': '-1.83', 'spread': '18.87', 'groupId': 'OG000'}]}]}, {'title': 'Peripheral Vision (n=42)', 'categories': [{'measurements': [{'value': '-4.17', 'spread': '25.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 54 weeks or at early termination', 'description': 'Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; n=number of subjects with evaluable data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'subjects received treatment', 'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegaptanib Sodium', 'description': 'All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.3', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-15', 'studyFirstSubmitDate': '2006-05-08', 'resultsFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2006-05-09', 'lastUpdatePostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-01', 'studyFirstPostDateStruct': {'date': '2006-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)', 'timeFrame': 'Baseline, 54 Weeks', 'description': 'Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Visual Acuity', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 54 weeks', 'description': 'Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.'}, {'measure': 'Number of Subjects Gaining Vision', 'timeFrame': '54 weeks or at early termination', 'description': 'Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.'}, {'measure': 'Number of Subjects Maintaining Vision', 'timeFrame': '54 weeks or at early termination', 'description': 'Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.'}, {'measure': 'Number of Subjects With Severe Visual Loss', 'timeFrame': '54 weeks or at early termination', 'description': 'Subjects with severe visual loss: loss from baseline of \\>= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.'}, {'measure': 'Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)', 'timeFrame': '54 weeks', 'description': 'Subjects with improving scores are those with \\> 20/200 at Baseline and progressing to =\\< 20/200 at Week 54.\n\nSubjects with no change are those with \\> 20/200 at Baseline and remaining at \\> 20/200 at Week 54.'}, {'measure': 'Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).', 'timeFrame': 'Baseline, 54 weeks or at early termination', 'description': 'Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5751016&StudyName=Evaluation%20Of%20Safety%20And%20Efficacy%20Of%200.3%20Mg/Eye%20Macugen%20In%20Patients%20With%20Small%20Age-Related%20Macular%20Degeneration%20Lesions', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas\n* Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)\n* Women must be using 2 forms of effective contraception\n* Adequate hematological, renal and liver functions\n\nExclusion Criteria:\n\n* Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area\n* Any extrafoveal choroidal neovascularization\n* Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment\n* Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.\n* Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis'}, 'identificationModule': {'nctId': 'NCT00324116', 'briefTitle': 'Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions', 'orgStudyIdInfo': {'id': 'A5751016'}}, 'armsInterventionsModule': {'armGroups': 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