Macular Degeneration
Conditions
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.
Interventions
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
Sponsors
ITEC GROUP 3
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) | Baseline, 54 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Gaining Vision | 54 weeks or at early termination | 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 | 54 weeks or at early termination | 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. |
| Change From Baseline in Visual Acuity | Baseline, 6 weeks, 12 weeks, 54 weeks | 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 With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) | 54 weeks | 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). | Baseline, 54 weeks or at early termination | 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. |
| Number of Subjects With Severe Visual Loss | 54 weeks or at early termination | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pegaptanib Sodium All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Lack of Efficacy | 17 |
| Overall Study | Other | 5 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Pegaptanib Sodium |
|---|---|
| Age Continuous | 76.3 years STANDARD_DEVIATION 6.7 |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / — |
| serious Total, serious adverse events | 8 / — |
Outcome results
Primary
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.
Time frame: Baseline, 54 Weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) | Responders | 40 participants |
| Pegaptanib Sodium | Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) | Non-Responders | 7 participants |
| Pegaptanib Sodium | Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) | Censored (subjects with missing data) | 33 participants |
95% CI: [76, 95]
Secondary
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.
Time frame: Baseline, 6 weeks, 12 weeks, 54 weeks
Population: FAS; n=number of subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib Sodium | Change From Baseline in Visual Acuity | 6 weeks (n=76) | -4.29 score on scale | Standard Deviation 11.11 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity | 12 weeks (n=74) | -5.86 score on scale | Standard Deviation 13.79 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity | 54 weeks (n=49) | -11.12 score on scale | Standard Deviation 17.96 |
Comparison: 6 weeks95% CI: [-6.83, -1.75]
Comparison: 12 weeks95% CI: [-9.06, -2.67]
Comparison: 54 weeks95% CI: [-16.28, -5.96]
Secondary
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.
Time frame: Baseline, 54 weeks or at early termination
Population: FAS; n=number of subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Composite (n=25) | -2.25 score on scale | Standard Deviation 15.71 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | General Health (n=42) | -4.17 score on scale | Standard Deviation 14.52 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | General Vision (n=41) | 3.90 score on scale | Standard Deviation 16.26 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Ocular Pain (n=43) | 0.35 score on scale | Standard Deviation 15.29 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Near Vision Activities (n=43) | -3.88 score on scale | Standard Deviation 27.6 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Distance Vision Activities (n=43) | -6.78 score on scale | Standard Deviation 23.68 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Social Functioning (n=43) | -0.58 score on scale | Standard Deviation 24.84 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Role Difficulties (n=41) | -4.39 score on scale | Standard Deviation 26.46 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Dependency (n=41) | -5.28 score on scale | Standard Deviation 22.15 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Driving (n=27) | -3.70 score on scale | Standard Deviation 30.67 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Color Vision (n=41) | -1.83 score on scale | Standard Deviation 18.87 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Peripheral Vision (n=42) | -4.17 score on scale | Standard Deviation 25.25 |
| Pegaptanib Sodium | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Mental Health Activities (n=43) | -0.30 score on scale | Standard Deviation 20.45 |
Secondary
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.
Time frame: 54 weeks or at early termination
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Subjects Gaining Vision | Gained | 4 participant |
| Pegaptanib Sodium | Number of Subjects Gaining Vision | Did not gain | 74 participant |
| Pegaptanib Sodium | Number of Subjects Gaining Vision | Assessment Not Done | 2 participant |
95% CI: [1.61, 11.32]
Secondary
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.
Time frame: 54 weeks or at early termination
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Subjects Maintaining Vision | Maintained | 18 participants |
| Pegaptanib Sodium | Number of Subjects Maintaining Vision | Did not maintain | 60 participants |
| Pegaptanib Sodium | Number of Subjects Maintaining Vision | Not Done | 2 participants |
95% CI: [14.22, 32.11]
Secondary
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.
Time frame: 54 weeks
Population: FAS; n=77 (number of Subjects at Baseline with \>20/200 Visual Acuity)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) | Improved | 20 participants |
| Pegaptanib Sodium | Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) | No Change | 57 participants |
95% CI: [16.28, 34.81]
Secondary
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.
Time frame: 54 weeks or at early termination
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Subjects With Severe Visual Loss | Severe Loss | 11 participants |
| Pegaptanib Sodium | Number of Subjects With Severe Visual Loss | Not severe loss | 67 participants |
| Pegaptanib Sodium | Number of Subjects With Severe Visual Loss | Not Done | 2 participants |
95% CI: [7.39, 22.24]