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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00324116
• Collaborator: ITEC GROUP 3 (Other)
• Enrollment: 81
• Locations: 34
• Arm: 1
• Duration (Months): 25
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: pegaptanib sodium (Macugen)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active	Drug: pegaptanib sodium (Macugen); 0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.; Other Names: MACUGEN

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Angers	Cedex 09	France	49933
2	Pfizer Investigational Site	Lyon	Cedex 4	France	69317
3	Pfizer Investigational Site	Besancon	Cedex	France	25030
4	Pfizer Investigational Site	Creteil	Cedex	France	94010
5	Pfizer Investigational Site	Macon	Cedex	France	71018
6	Pfizer Investigational Site	Poitiers	Cedex	France	86021
7	Pfizer Investigational Site	Bayonne		France	64100
8	Pfizer Investigational Site	Belfort Cedex		France	90016
9	Pfizer Investigational Site	Bordeaux		France	33076
10	Pfizer Investigational Site	Bordeaux		France	33100
11	Pfizer Investigational Site	Brest		France	29200
12	Pfizer Investigational Site	DIJON Cedex		France	21033
13	Pfizer Investigational Site	La Rochefoucauld		France	16110
14	Pfizer Investigational Site	La Tronche		France	38700
15	Pfizer Investigational Site	Lille		France	59800
16	Pfizer Investigational Site	Limoges Cedex 1		France	87042
17	Pfizer Investigational Site	Lyon		France	69003
18	Pfizer Investigational Site	Marseille		France	13008
19	Pfizer Investigational Site	Montpellier		France	34000
20	Pfizer Investigational Site	Montpellier		France	34070
21	Pfizer Investigational Site	MULHOUSE Cedex 1		France	68070
22	Pfizer Investigational Site	Nancy		France	54000
23	Pfizer Investigational Site	Nantes Cedex 1		France	44093
24	Pfizer Investigational Site	Paris cedex 12		France	75557
25	Pfizer Investigational Site	PARIS Cedex 19		France	75940
26	Pfizer Investigational Site	Paris		France	75006
27	Pfizer Investigational Site	Paris		France	75015
28	Pfizer Investigational Site	Rives		France	38140
29	Pfizer Investigational Site	Rouen		France	76000
30	Pfizer Investigational Site	Saint-Herblain		France	44819
31	Pfizer Investigational Site	Strasbourg Cedex		France	67091
32	Pfizer Investigational Site	Strasbourg		France	67000
33	Pfizer Investigational Site	Toulouse		France	31054
34	Pfizer Investigational Site	Toulouse		France	31200

Sponsors and Collaborators

• Pfizer
• ITEC GROUP 3

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00324116
• Other Study ID Numbers: A5751016
• First Posted: May 10, 2006
• Last Update Posted: Mar 23, 2010
• Last Verified: Mar 1, 2010

• Additional relevant MeSH terms: Macular Degeneration

Study Results

Participant Flow

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Period Title: Overall Study
STARTED	81
COMPLETED	49
NOT COMPLETED	32

Baseline Characteristics

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Participants	81
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.3 (6.7)
Sex: Female, Male (Count of Participants)
Female	47 58%
Male	34 42%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Measure Participants	80
Responders	40 49.4%
Non-Responders	7 8.6%
Censored (subjects with missing data)	33 40.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib Sodium
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent responders
	Estimated Value	85
	Confidence Interval	() 95%; 76 to 95
	Parameter Dispersion	Type: Value:
	Estimation Comments	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.

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS; n=number of subjects with evaluable data.

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Measure Participants	80
6 weeks (n=76)	-4.29 (11.11)
12 weeks (n=74)	-5.86 (13.79)
54 weeks (n=49)	-11.12 (17.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib Sodium
	Comments	6 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.29
	Confidence Interval	() 95%; -6.83 to -1.75
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for the change in mean value obtained from one sample t-test.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib Sodium
	Comments	12 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.86
	Confidence Interval	() 95%; -9.06 to -2.67
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for the change in mean value obtained from one sample t-test.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib Sodium
	Comments	54 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.12
	Confidence Interval	() 95%; -16.28 to -5.96
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% CI for the change in mean value obtained from one sample t-test.

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Measure Participants	80
Gained	4
Did not gain	74
Assessment Not Done	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib Sodium
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of subjects
	Estimated Value	5.00
	Confidence Interval	() 95%; 1.61 to 11.32
	Parameter Dispersion	Type: Value:
	Estimation Comments	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

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Measure Participants	80
Maintained	18 22.2%
Did not maintain	60 74.1%
Not Done	2 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib Sodium
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of subjects
	Estimated Value	22.50
	Confidence Interval	() 95%; 14.22 to 32.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	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.

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Measure Participants	80
Severe Loss	11 13.6%
Not severe loss	67 82.7%
Not Done	2 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib Sodium
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of subjects
	Estimated Value	13.75
	Confidence Interval	() 95%; 7.39 to 22.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	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.

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS; n=77 (number of Subjects at Baseline with >20/200 Visual Acuity)

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Measure Participants	80
Improved	20 24.7%
No Change	57 70.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib Sodium
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of subjects
	Estimated Value	25.97
	Confidence Interval	() 95%; 16.28 to 34.81
	Parameter Dispersion	Type: Value:
	Estimation Comments	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.

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

FAS; n=number of subjects with evaluable data.

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Measure Participants	80
Composite (n=25)	-2.25 (15.71)
General Health (n=42)	-4.17 (14.52)
General Vision (n=41)	3.90 (16.26)
Ocular Pain (n=43)	0.35 (15.29)
Near Vision Activities (n=43)	-3.88 (27.60)
Distance Vision Activities (n=43)	-6.78 (23.68)
Social Functioning (n=43)	-0.58 (24.84)
Mental Health Activities (n=43)	-0.30 (20.45)
Role Difficulties (n=41)	-4.39 (26.46)
Dependency (n=41)	-5.28 (22.15)
Driving (n=27)	-3.70 (30.67)
Color Vision (n=41)	-1.83 (18.87)
Peripheral Vision (n=42)	-4.17 (25.25)

Adverse Events

Arm/Group Title	Pegaptanib Sodium
Arm/Group Description	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
All Cause Mortality
	Pegaptanib Sodium
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pegaptanib Sodium
	Affected / at Risk (%)	# Events
Total	8/ (NaN)
Cardiac disorders
Cardiac failure	1/81 (1.2%)
Cardiac failure acute	1/81 (1.2%)
Angina unstable	1/81 (1.2%)
Eye disorders
Cataract operation	1/81 (1.2%)
Macular degeneration	1/81 (1.2%)
Retinal haemorrhage	1/81 (1.2%)
Gastrointestinal disorders
Peritonitis	1/81 (1.2%)
Infections and infestations
Pyelonephritis	1/81 (1.2%)
Psychiatric disorders
Suicide attempt	1/81 (1.2%)
Other (Not Including Serious) Adverse Events
	Pegaptanib Sodium
	Affected / at Risk (%)	# Events
Total	28/ (NaN)
Eye disorders
Conjunctival haemorrhage	6/81 (7.4%)
Eye pain	7/81 (8.6%)
Macular degeneration	8/81 (9.9%)
Myodesopsia	12/81 (14.8%)
General disorders
Pain	5/81 (6.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.