Photodynamic therapy for neovascular age‐related macular degeneration

Richard Wormald; Jennifer R Evans; Liam L Smeeth; Katherine S Henshaw

doi:10.1002/14651858.CD002030.pub3

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Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 3

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.1 Loss of 3 or more lines (15 or more letters) visual acuity at 12 months.

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Figure 4

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.3 Loss of 6 or more lines (30 or more letters) visual acuity at 12 months.

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Figure 5

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.2 Loss of 3 or more lines (15 or more letters) visual acuity at 24 months.

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Figure 6

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.4 Loss of 6 or more lines (30 or more letters) visual acuity at 24 months.

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Figure 7

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.7 Gain of 3 or more lines (15 or more letters) of visual acuity at 12 months.

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Figure 8

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.8 Gain of 3 or more lines (15 or more letters) of visual acuity at 24 months.

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Figure 9

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.9 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 12 months.

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Figure 10

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.10 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 24 months.

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Figure 11

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.11 Adverse effects: acute severe visual acuity decrease.

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Figure 12

Forest plot of comparison: 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, outcome: 1.14 Adverse effects: infusion‐related back pain.

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Analysis 1.1

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 1 Loss of 3 or more lines (15 or more letters) visual acuity at 12 months.

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Analysis 1.2

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 2 Loss of 3 or more lines (15 or more letters) visual acuity at 24 months.

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Analysis 1.3

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 3 Loss of 6 or more lines (30 or more letters) visual acuity at 12 months.

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Analysis 1.4

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 4 Loss of 6 or more lines (30 or more letters) visual acuity at 24 months.

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Analysis 1.5

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 5 Loss of 6 or more letters of contrast sensitivity at 24 months.

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Analysis 1.6

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 6 Loss of 15 or more letters of contrast sensivitiy at 24 mths.

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Analysis 1.7

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 7 Gain of 3 or more lines (15 or more letters) of visual acuity at 12 months.

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Analysis 1.8

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 8 Gain of 3 or more lines (15 or more letters) of visual acuity at 24 months.

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Analysis 1.9

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 9 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 12 months.

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Analysis 1.10

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 10 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 24 months.

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Analysis 1.11

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 11 Adverse effects: acute severe visual acuity decrease.

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Analysis 1.12

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 12 Adverse effects: visual disturbance.

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Analysis 1.13

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 13 Adverse effects: injection site.

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Analysis 1.14

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 14 Adverse effects: infusion‐related back pain.

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Analysis 1.15

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 15 Adverse effects: allergic reactions.

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Analysis 1.16

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 16 Adverse effects: photosensitivity reactions.

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Analysis 1.17

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 17 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 12 months.

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Analysis 1.18

Comparison 1 PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO, Outcome 18 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 24 months.

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Summary of findings for the main comparison. Photodynamic therapy with verteporfin compared to photodynamic therapy with 5% dextrose in water for neovascular age‐related macular degeneration

Photodynamic therapy with verteporfin compared to photodynamic therapy with 5% dextrose in water for neovascular age‐related macular degeneration
Patient or population: patients with neovascular age‐related macular degeneration Settings: hospital or office Intervention: photodynamic therapy with verteporfin Comparison: photodynamic therapy with 5% dextrose in water
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	photodynamic therapy with 5% dextrose in water	photodynamic therapy with verteporfin
Loss of 3 or more lines (15 or more letters) visual acuity ETDRS chart Follow‐up: 24 months	609 per 1000	487 per 1000 (445 to 536)	RR 0.8 (0.73 to 0.88)	1381 (4 studies)	⊕⊕⊕⊕ high
Loss of 6 or more lines (30 or more letters) visual acuity ETDRS chart Follow‐up: 24 months	333 per 1000	220 per 1000 (176 to 276)	RR 0.66 (0.53 to 0.83)	1381 (4 studies)	⊕⊕⊕⊕ high
Gain of 3 or more lines (15 or more letters) Follow‐up: 24 months	36 per 1000	80 per 1000 (43 to 151)	RR 2.23 (1.19 to 4.19)	941 (3 studies)	⊕⊕⊕⊕ high
Adverse effects: acute severe visual acuity decrease Follow‐up: 7 days	3 per 1000	11 per 1000 (3 to 48)	RR 3.75 (0.87 to 16.12)	1075 (3 studies)	⊕⊕⊕⊝ moderate¹
Adverse effects: infusion‐related back pain	2 per 1000	20 per 1000 (6 to 70)	RR 9.93 (2.82 to 35.02)	1439 (4 studies)	⊕⊕⊕⊕ high²
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Serious imprecision: confidence intervals include 1 (no effect). ² Not downgraded for imprecision: confidence intervals wide however do not include 1 (no effect).

Summary of findings for the main comparison. Photodynamic therapy with verteporfin compared to photodynamic therapy with 5% dextrose in water for neovascular age‐related macular degeneration

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Table 1. Summary of reports of the TAP and VIP trials

Title	Year	Content
TAP 1	1999	12 month outcomes
TAP 2	2001	24 month outcomes
TAP 3	2002	Baseline lesion type subgroup analysis
TAP 4	2002	Contrast sensitivity outcomes
TAP 5	2002	Open label 36 month outcomes
TAP 6	2004	Natural history of minimally classic lesions
TAP 7	2005	48 month open label outcomes
TAP 8	2006	60 month open label outcomes
TAP & VIP 1	2003	Effect of baseline lesion characteristics and vision on outcome
TAP & VIP 2	2003	Fluorescein angiography guidelines for grading lesions and repeatability
TAP & VIP 3	2004	Acute Severe Visual Acuity Decrease
VIP 1	2001	12 month outcomes for neovascular membranes due to pathologic myopia
VIP 2	2001	24 month outcomes occult no classic lesions
VIP 3	2003	24 month outcomes for neovascular membranes due to pathologic myopia
VIP 4	2006	Natural history of large occult lesions

Table 1. Summary of reports of the TAP and VIP trials

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Table 2. Outcome reporting grid

	TAP 1999	VIP 2001	VIM 2005	VIO 2007
3+ lines 12 mths	✓	✓	✓	✓
3+ lines 24 mths	✓	✓	✓	✓
6+lines 12 mths	✓	✓(subgroup only)	✓	✓
6+ lines 24 mths	✓	✓	✓	✓
Final mean VA 12 mths	Mean value reported but no measures of variability	✓(subgroup only)	Median value only reported	✓
Final mean VA 24 mths	Mean value reported but no measures of variability	✓(subgroup only)	Median value only reported	✓
Change in VA 12 mths	Mean value reported but no measures of variability	✓(subgroup only)	Mean change reported in graph but no measures of variability	✓
Change in VA 24 mths	Mean value reported but no measures of variability	✓(subgroup only)	Mean change reported in graph but no measures of variability	✓
Contrast sensitivity 12 mths	✓	Outcome probably measured but not clear if analysed	Not reported; unclear if data collected	Not reported; unclear if data collected
Contrast sensitivity 24 mths	✓	✓(subgroup only)	Not reported; unclear if data collected	Not reported; unclear if data collected
New vessel growth 12 mths	✓		"Angiographic progression to predominantly classic CNV"	Clear that angiographic outcomes analysed but only reported as not significant
New vessel growth 24 mths	✓		"Angiographic progression to predominantly classic CNV"	Clear that angiographic outcomes analysed but only reported as not significant
Quality of life	QOL study mentioned in protocol but no data reported		Not reported; unclear if data collected	Not reported; unclear if data collected
Adverse outcomes
Visual disturbance	✓	✓	✓	Not reported
Vitreous haemorrhage	✓	Not reported	Not reported	Not reported
Retinal capillary nonperfusion	✓	Not reported	Not reported	Not reported
Injection site adverse event	✓	✓	✓	Not reported
Infusion‐related back pain	✓	✓	✓	✓
Allergic reactions	✓	✓	✓	Not reported
Photosensitivity reactions	✓	✓	✓	Not reported
Severe vision decrease within 7 days	✓	✓	✓	Not reported
Deaths	Not reported	Not reported	✓	✓
Retinal vascular occlusive events	Not reported	Not reported	✓	Not reported
Subretinal/intraretinal haemorrhage	Not reported	Not reported	✓	Not reported
Discontinuation	Not reported	Not reported	Not reported	✓

Table 2. Outcome reporting grid

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Table 3. Mean change in visual acuity

Number of letters visual acuity lost	12 months			24 months
Number of letters visual acuity lost	PDT	Placebo	Difference	PDT	Placebo	Difference
TAP 1999*	11	17.5	6.5	13.4	19.6	6.2
VIP 2001	15.6	20.8	5.2	19	25.5	6.5
VIM 2005**	9	13.5	4.5	16	21	5
VIO 2007***	11.2	13.3	2.1	14.8	17.8	3
calculated from reported number of lines lost * median score: reported test of difference between 2 groups: P (12 months) =0.36; p(24 months) = 0.12 *** reported test of difference between 2 groups: P (12 months) =0.26; p(24 months) = 0.14

Table 3. Mean change in visual acuity

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Table 4. Final visual acuity score

Number of letters visual acuity	12 months			24 months
Number of letters visual acuity	PDT	Placebo	Difference	PDT	Placebo	Difference
TAP 1999	42	35	7	39.4	32.9	6.5
VIP 2001	50	44	6	47	40	7
VIM 2005	49	39	10	41.5	36	‐5.5
VIO 2007	45.9	42.4	3.5*	42.3	37.8	4.5**
P = 0.11 (2 tailed ttest calculated from data reported: PDT group SD=19.8, placebo group SD=18.3). *P = 0.05. (2 tailed ttest calculated from data reported: PDT group SD=20.8, placebo group SD=18.0).

Table 4. Final visual acuity score

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Table 5. Lesion area composed of classic CNV

Lesion area composed of classic CNV	50% or more "predominantly classic"	Some classic CNV but less than 50%	No classic CNV (occult only)	Unclear
TAP 1999	40%	50%	9%	1%
VIP 2001	6%	17%	68%	10%
VIM 2005	0%	78%	13%	9%
VIO 2007	No data provided however patients enrolled in the trial had to have "occult CNV with evidence of disease progression"

Table 5. Lesion area composed of classic CNV

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Comparison 1. PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Loss of 3 or more lines (15 or more letters) visual acuity at 12 months Show forest plot	4	1386	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.69, 0.93]

2 Loss of 3 or more lines (15 or more letters) visual acuity at 24 months Show forest plot	4	1381	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.73, 0.88]

3 Loss of 6 or more lines (30 or more letters) visual acuity at 12 months Show forest plot	4	1305	Risk Ratio (M‐H, Random, 95% CI)	0.70 [0.56, 0.88]

4 Loss of 6 or more lines (30 or more letters) visual acuity at 24 months Show forest plot	4	1381	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.53, 0.83]

5 Loss of 6 or more letters of contrast sensitivity at 24 months Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 Loss of 15 or more letters of contrast sensivitiy at 24 mths Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

7 Gain of 3 or more lines (15 or more letters) of visual acuity at 12 months Show forest plot	3	941	Risk Ratio (M‐H, Random, 95% CI)	2.19 [0.99, 4.83]

8 Gain of 3 or more lines (15 or more letters) of visual acuity at 24 months Show forest plot	3	941	Risk Ratio (M‐H, Random, 95% CI)	2.55 [1.31, 4.99]

9 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 12 months Show forest plot	4	1267	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.68, 0.87]

9.1 No classic CNV	3	645	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.67, 0.96]
9.2 Classic CNV > 0% to < 50%	2	379	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.70, 1.14]
9.3 Classic CNV > 50% (predominantly classic)	1	243	Risk Ratio (M‐H, Fixed, 95% CI)	0.54 [0.41, 0.71]
10 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 24 months Show forest plot	4	1375	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.73, 0.89]

10.1 No classic CNV	3	683	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.72, 0.95]
10.2 Classic CNV > 0 to < 50%	3	431	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.77, 1.10]
10.3 Classic CNV > 50% (predominantly classic)	2	261	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.48, 0.75]
11 Adverse effects: acute severe visual acuity decrease Show forest plot	3	1075	Risk Ratio (M‐H, Fixed, 95% CI)	3.75 [0.87, 16.12]

12 Adverse effects: visual disturbance Show forest plot	3	1075	Risk Ratio (M‐H, Fixed, 95% CI)	1.56 [1.21, 2.01]

13 Adverse effects: injection site Show forest plot	3	1075	Odds Ratio (M‐H, Fixed, 95% CI)	2.09 [1.29, 3.39]

14 Adverse effects: infusion‐related back pain Show forest plot	4	1439	Risk Ratio (M‐H, Fixed, 95% CI)	9.93 [2.82, 35.02]

15 Adverse effects: allergic reactions Show forest plot	2	948	Odds Ratio (M‐H, Fixed, 95% CI)	0.94 [0.34, 2.56]

16 Adverse effects: photosensitivity reactions Show forest plot	2	948	Odds Ratio (M‐H, Fixed, 95% CI)	5.37 [1.01, 28.60]

17 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 12 months Show forest plot	3	662	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.67, 0.97]

17.1 No classic CNV	2	588	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.69, 1.01]
17.2 Classic CNV > 0% to < 50%	1	74	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.31, 1.09]
17.3 Classic CNV > 50% (predominantly classic)	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
18 Subgroup analysis: lesion area composed of classic CNV. Loss of 3 or more lines at 24 months Show forest plot	3	766	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.74, 0.97]

18.1 No classic CNV	2	622	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.73, 0.98]
18.2 Classic CNV > 0 to < 50%	2	125	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.63, 1.20]
18.3 Classic CNV > 50% (predominantly classic)	1	19	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.42, 1.19]

Comparison 1. PHOTODYNAMIC THERAPY WITH VERTEPORFIN VERSUS PLACEBO

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