Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

pegaptanib sodium (Macugen)

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS) Women must be using 2 forms of effective contraception Adequate hematological, renal and liver functions Exclusion Criteria: Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area Any extrafoveal choroidal neovascularization Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment 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. Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

Outcomes

Primary Outcome Measures

Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)

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.

Secondary Outcome Measures

Change From Baseline in 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. Change: mean score at observation minus mean score at baseline.

Number of Subjects Gaining Vision

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.

Number of Subjects Maintaining Vision

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.

Number of Subjects With Severe Visual Loss

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.

Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)

Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54. Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54.

Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).

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.

Full Information

NCT ID

NCT00324116

First Posted

May 8, 2006

Last Updated

March 15, 2010

Sponsor

Pfizer

Collaborators

ITEC GROUP 3

1. Study Identification

Unique Protocol Identification Number

NCT00324116

Brief Title

Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

Collaborators

ITEC GROUP 3

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

pegaptanib sodium (Macugen)

Other Intervention Name(s)

MACUGEN

Intervention Description

0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.

Primary Outcome Measure Information:

Title

Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)

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.

Time Frame

Baseline, 54 Weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Visual Acuity

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.

Time Frame

Baseline, 6 weeks, 12 weeks, 54 weeks

Title

Number of Subjects Gaining Vision

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.

Time Frame

54 weeks or at early termination

Title

Number of Subjects Maintaining Vision

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.

Time Frame

54 weeks or at early termination

Title

Number of Subjects With Severe Visual Loss

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.

Time Frame

54 weeks or at early termination

Title

Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)

Description

Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54. Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54.

Time Frame

54 weeks

Title

Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).

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.

Time Frame

Baseline, 54 weeks or at early termination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS) Women must be using 2 forms of effective contraception Adequate hematological, renal and liver functions Exclusion Criteria: Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area Any extrafoveal choroidal neovascularization Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment 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. Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Angers

State/Province

Cedex 09

ZIP/Postal Code

49933

Country

France

Facility Name

Pfizer Investigational Site

City

Lyon

State/Province

Cedex 4

ZIP/Postal Code

69317

Country

France

Facility Name

Pfizer Investigational Site

City

Besancon

State/Province

Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Pfizer Investigational Site

City

Creteil

State/Province

Cedex

ZIP/Postal Code

94010

Country

France

Facility Name

Pfizer Investigational Site

City

Macon

State/Province

Cedex

ZIP/Postal Code

71018

Country

France

Facility Name

Pfizer Investigational Site

City

Poitiers

State/Province

Cedex

ZIP/Postal Code

86021

Country

France

Facility Name

Pfizer Investigational Site

City

Bayonne

ZIP/Postal Code

64100

Country

France

Facility Name

Pfizer Investigational Site

City

Belfort Cedex

ZIP/Postal Code

90016

Country

France

Facility Name

Pfizer Investigational Site

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Pfizer Investigational Site

City

Bordeaux

ZIP/Postal Code

33100

Country

France

Facility Name

Pfizer Investigational Site

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Pfizer Investigational Site

City

DIJON Cedex

ZIP/Postal Code

21033

Country

France

Facility Name

Pfizer Investigational Site

City

La Rochefoucauld

ZIP/Postal Code

16110

Country

France

Facility Name

Pfizer Investigational Site

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

Pfizer Investigational Site

City

Lille

ZIP/Postal Code

59800

Country

France

Facility Name

Pfizer Investigational Site

City

Limoges Cedex 1

ZIP/Postal Code

87042

Country

France

Facility Name

Pfizer Investigational Site

City

Lyon

ZIP/Postal Code

69003

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

ZIP/Postal Code

13008

Country

France

Facility Name

Pfizer Investigational Site

City

Montpellier

ZIP/Postal Code

34000

Country

France

Facility Name

Pfizer Investigational Site

City

Montpellier

ZIP/Postal Code

34070

Country

France

Facility Name

Pfizer Investigational Site

City

MULHOUSE Cedex 1

ZIP/Postal Code

68070

Country

France

Facility Name

Pfizer Investigational Site

City

Nancy

ZIP/Postal Code

54000

Country

France

Facility Name

Pfizer Investigational Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Pfizer Investigational Site

City

Paris cedex 12

ZIP/Postal Code

75557

Country

France

Facility Name

Pfizer Investigational Site

City

PARIS Cedex 19

ZIP/Postal Code

75940

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75006

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Pfizer Investigational Site

City

Rives

ZIP/Postal Code

38140

Country

France

Facility Name

Pfizer Investigational Site

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

Pfizer Investigational Site

City

Saint-Herblain

ZIP/Postal Code

44819

Country

France

Facility Name

Pfizer Investigational Site

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Pfizer Investigational Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Pfizer Investigational Site

City

Toulouse

ZIP/Postal Code

31054

Country

France

Facility Name

Pfizer Investigational Site

City

Toulouse

ZIP/Postal Code

31200

Country

France

12. IPD Sharing Statement

Links:

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

Description

To obtain contact information for a study center near you, click here.

Macular Degeneration

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial