Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study

Figures & data

Table 1 Baseline demographics of patients treated with intravitreal dexamethasone implant injection

	All patients (N=101)	DME (n=24)	RVO (n=29)a	Uveitis (n=20)
Age, years
Mean (SD)	60.9 (14.8)	64.0 (11.2)	64.4 (12.0)	49.8 (16.7)
Range	11–89	36–83	31–81	11–79
Sex, % (n)
Female	34.7 (35)	33.3 (8)	17.2 (5)	50.0 (10)
Male	65.3 (66)	66.7 (16)	82.8 (24)	50.0 (10)
Race, % (n)
Asian	6.9 (7)	8.3 (2)	10.3 (3)	0.0 (0)
Black	3.0 (3)	4.2 (1)	0.0 (0)	10.0 (2)
Hispanic	2.0 (2)	0.0 (0)	6.9 (2)	0.0 (0)
Other	10.9 (11)	0.0 (0)	10.3 (3)	5.0 (1)
White	77.2 (78)	87.5 (21)	72.4 (21)	85.0 (17)
Selected baseline comorbidities, % (n)
Diabetes mellitus	27.7 (28)	100 (24)	13.8 (4)	0.0 (0)
Hypertension	55.4 (56)	91.7 (22)	72.4 (21)	30.0 (6)

Note:

a RVO cohort included branch (n=19) and central (n=11) forms.

Abbreviations: DME, diabetic macular edema; RVO, retinal vein occlusion; SD, standard deviation.

Table 2 Ocular diagnoses other than diabetic macular edema, retinal vein occlusion, and uveitis in study eyes included in the all eyes cohort

Ocular diagnosis	Study eyes (n)
Coat’s disease	1
Cystoid macular edema	1
Eales’ disease	1
Epiretinal membrane	7
Idiopathic cystoid macular edema	2
Irvine-Gass syndrome	3
Macular hole	1
Macular telangiectasia	5
Neovascular age-related macular degeneration	2
Post-laser tear	1
Retinal angioma	1
Retinal detachment	5
Retinal necrosis syndrome	2
Vitreomacular traction	1

Table 3 Study eye characteristics and treatments and procedures administered prior to intravitreal dexamethasone implant injection

Baseline parameter	All eyes (N=120)	DME (n=34)	RVO (n=30)	Uveitis (n=23)
Study eye characteristics
Baseline lens status, % (n)
Aphakic	0.8 (1)	0.0 (0)	0.0 (0)	0.0 (0)
Phakic	39.2 (47)	32.4 (11)	43.3 (13)	47.8 (11)
Pseudophakic	60.0 (72)	67.6 (23)	56.7 (17)	52.2 (12)
Macular edema prior to first injection, % (n)
<3 months	5.8 (7)	0.0 (0)	6.7 (2)	8.7 (2)
≥3 to <12 months	15.8 (19)	5.9 (2)	13.3 (4)	30.4 (7)
≥12 months	73.3 (88)	94.1 (32)	70.0 (21)	56.5 (13)
Unknown duration	5.0 (6)	0.0 (0)	10.0 (3)	4.3 (1)
Visual acuity
LogMAR (mean ± SE)	0.63±0.03	0.60±0.07	0.64±0.06	0.71±0.07
Snellen equivalent	20/86	20/81	20/88	20/102
Central retinal thickness, μm (mean ± SE)	474.4±18.2	450.4±26.0	434.8±37.4	517.2±40.3
Range, μm	180–1,035	180–690	218–866	285–872
Intraocular pressure, mmHg (mean ± SE)	14.4±0.4	15.5±0.9	15.6±0.7	12.3±0.8
History of steroid response, % (n)	25.0 (30)	29.4 (10)	16.7 (5)	34.8 (8)
Continuing prior IOP-lowering medication, % (n)	21.7 (26)	29.4 (10)	23.3 (7)	21.7 (5)
Prior treatments and procedures
Injections, % (n)
Intravitreal bevacizumab	31.7 (38)	47.1 (16)	36.7 (11)	17.4 (4)
Intravitreal ranibizumab	10.8 (13)	8.8 (3)	3.3 (1)	8.7 (2)
Intravitreal triamcinolone acetonide	42.5 (51)	38.2 (13)	30.0 (9)	65.2 (15)
Sub-Tenon’s triamcinolone acetonide	20.8 (25)	5.9 (2)	10.0 (3)	43.5 (10)
Systemic medications, % (n)
Cyclosporine	2.5 (3)	0.0 (0)	0.0 (0)	13.0 (3)
Methotrexate	5.8 (7)	0.0 (0)	0.0 (0)	30.4 (7)
Methylprednisolone	1.7 (2)	0.0 (0)	0.0 (0)	8.7 (2)
Mycophenolate mofetil	5.8 (7)	0.0 (0)	0.0 (0)	26.1 (6)
Prednisone	10.0 (12)	0.0 (0)	0.0 (0)	43.5 (10)
Surgical interventions, % (n)
Cataract surgery	60.0 (72)	67.6 (23)	56.7 (17)	52.2 (12)
Focal or grid laser	30.0 (36)	55.9 (19)	36.7 (11)	0.0 (0)
Glaucoma surgery	8.3 (10)	11.8 (4)	6.7 (2)	17.4 (4)
Membrane peel	14.2 (17)	17.6 (6)	16.7 (5)	13.0 (3)
Panretinal photocoagulation	22.5 (27)	55.9 (19)	23.3 (7)	0.0 (0)
Photodynamic therapy with verteporfin	2.5 (3)	0.0 (0)	0.0 (0)	0.0 (0)
Pneumatic retinopexy	2.5 (3)	2.9 (1)	3.3 (1)	0.0 (0)
Scleral buckling	2.5 (3)	0.0 (0)	0.0 (0)	4.3 (1)
Vitrectomy	47.5 (57)	55.9 (19)	40.0 (12)	30.4 (7)

Abbreviations: DME, diabetic macular edema; IOP, intraocular pressure; RVO, retinal vein occlusion; SE, standard error.

Table 4 Medications and procedures used adjunctively with intravitreal dexamethasone implant therapy

Treatment or procedure	All eyes (N=120)	DME (n=34)	RVO (n=30)	Uveitis (n=23)
Injections, % (n)
Intravitreal bevacizumab	7.5 (9)	8.8 (3)	10.0 (3)	13.0 (3)
Intravitreal dexamethasone implant	44.2 (53)	44.1 (15)	50.0 (15)	43.5 (10)
Intravitreal ranibizumab	1.7 (2)	2.9 (1)	3.3 (1)	0.0 (0)
Intravitreal triamcinolone acetonide	14.2 (17)	20.6 (7)	13.3 (4)	4.3 (1)
Sub-Tenon’s triamcinolone acetonide	1.7 (2)	0.0 (0)	0.0 (0)	8.7 (2)
Systemic medications, % (n)
Cyclosporine	4.2 (5)	0.0 (0)	0.0 (0)	17.4 (4)
Methotrexate	3.3 (4)	0.0 (0)	0.0 (0)	17.4 (4)
Mycophenolate mofetil	10.0 (12)	0.0 (0)	0.0 (0)	47.8 (11)
Prednisone	3.3 (4)	0.0 (0)	0.0 (0)	17.4 (4)
Laser or surgical interventions, % (n)
Fluocinolone acetonide implant	0.8 (1)	0.0 (0)	0.0 (0)	4.3 (1)
Focal or grid laser	4.2 (5)	5.9 (2)	10.0 (3)	0.0 (0)
Laser barricade	1.7 (2)	0.0 (0)	0.0 (0)	8.7 (2)
Membrane peel	4.2 (5)	8.8 (3)	3.3 (1)	4.3 (1)
Panretinal photocoagulation	0.8 (1)	0.0 (0)	0.0 (0)	0.0 (0)
Vitrectomy	8.3 (10)	11.8 (4)	3.3 (1)	8.7 (2)
No treatment/procedure other than DEX implant, % (n)	60.0 (72)	58.8 (20)	73.3 (22)	21.7 (5)

Abbreviations: DEX implant, intravitreal dexamethasone implant; DME, diabetic macular edema; RVO, retinal vein occlusion.

Figure 1 Peak mean change in BCVA (Snellen line equivalent) from baseline at 2–26 weeks after the last DEX implant injection.

Notes: *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001 for intragroup comparison with corresponding baseline values prior to treatment with the DEX implant. Missing data points resulted from lack of baseline visual acuity in the medical chart or lack of follow-up at a minimum of 12±2 weeks after the last DEX implant. N represents the total number of eyes in each group, and n represents number of eyes with follow-up data for analysis. As vision was analyzed after the last injection, patients initially treated with the DEX implant and who received subsequent reinjections may not have had sufficient follow-up data in their medical charts for analysis purposes.
Abbreviations: BCVA, best-corrected visual acuity; DEX, intravitreal dexamethasone; DME, diabetic macular edema; RVO, retinal vein occlusion; SE, standard error.

Figure 2 Proportion of study eyes with gains of 1 or more (A), 2 or more (B), and 3 or more (C) BCVA lines of vision after the first, second, and third DEX implant injection.

Notes: Data for the proportion of eyes with gains of 1 or more, 2 or more, and 3 or more lines of vision was calculated at any available study visit. For each group, N represents the total number of eyes available for analysis, and n represents the number of study eyes achieving ≥1, ≥2, or ≥3 lines of vision gain.
Abbreviations: BCVA, best-corrected visual acuity; DEX, intravitreal dexamethasone; DME, diabetic macular edema; RVO, retinal vein occlusion.

Figure 3 Peak mean change in CRT from baseline at 2–26 weeks after the last DEX implant injection.

Notes: **P<0.01, ***P<0.001, ****P<0.0001 for intragroup comparison with corresponding baseline values prior to treatment with DEX implants. Missing data points resulted from lack of baseline CRT in the medical chart or lack of follow-up a minimum of 12±2 weeks after the last DEX implant. N represents the total number of eyes in each group, and n represents number of eyes with follow-up data for analysis; as vision was analyzed after the last injection, patients initially treated with DEX implant and received subsequent reinjections may not have had sufficient follow-up data in their medical charts for analysis purposes.
Abbreviations: CRT, central retinal thickness; DEX, intravitreal dexamethasone, DME, diabetic macular edema; RVO, retinal vein occlusion; SE, standard error.

Figure 4 OCT retinal images from representative DME, BRVO, and uveitis study eyes at baseline and after treatment with the DEX implant. BCVA and CRT by OCT are indicated.

Abbreviations: BCVA, best-corrected visual acuity; CRT, central retinal thickness; DEX, intravitreal dexamethasone; DME, diabetic macular edema; BRVO, branch retinal vein occlusion; OCT, optical coherence tomography.

Table 5 Treatment-related adverse events occurring in >1% of all patients

System Organ Class/Preferred Term	All patients (N =101)		DME (n=24)		RVO (n=29)		Uveitis (n= 20)
	Patients, % (n)	Events, n	Patients, % (n)	Events, n	Patients, % (n)	Events, n	Patients, % (n)	Events, n
All adverse events	33.7 (34)	52	33.3 (8)	11	37.9 (11)	16	25.0 (5)	8
Investigations
IOP increased	20.8 (21)	31	25.0 (6)	11	27.6 (8)	11	10.0 (2)	2
Eye disorders
Cataract subcapsular	2.0 (2)	4	0.0 (0)	0	0.0 (0)	0	5.0 (1)	2
Visual acuity reduced	2.0 (2)	2	0.0 (0)	0	6.9 (2)	2	0.0 (0)	0
Injury, poisoning, and procedural complications
Retinal detachment	2.0 (2)	3	0.0 (0)	0	0.0 (0)	0	5.0 (1)	1

Abbreviations: DME, diabetic macular edema; IOP, intraocular pressure; RVO, retinal vein occlusion.

Figure 5 Increase in IOP following treatment with the DEX implant.

Notes: Proportion of study eyes with increases in IOP ≥10 mmHg compared with baseline and absolute IOP readings ≥25 mmHg and ≥35 mmHg recorded at any follow-up visit after DEX implant injection. Data for the proportion of eyes with IOP readings ≥25 mmHg and ≥35 mmHg were calculated at any available study visit. One eye each in the uveitis and RVO subgroups were not included in the respective total available sample sizes for the analysis of IOP increase ≥10 mmHg because of missing baseline IOPs in medical charts. For each group, N represents the total number of eyes available for analysis, and n represents the number of study eyes with respective increases in IOP.
Abbreviations: DEX, intravitreal dexamethasone; DME, diabetic macular edema; IOP, intraocular pressure; RVO, retinal vein occlusion.

Figure 6 The proportion of study eyes requiring use of topical IOP-lowering medication(s) at any follow-up visit after DEX implant injection.

Notes: For each group, N represents the total number of eyes available for analysis, and n represents the total number of study eyes requiring IOP-lowering medication.
Abbreviations: DEX, intravitreal dexamethasone; DME, diabetic macular edema; IOP, intraocular pressure; RVO, retinal vein occlusion.

Table S1 Information collected at each retrospective study visit

Information collected	Visit 1 medical historya	Visit 2 injection visitsb	Visit 3 post-injection follow-upc
Informed consent (if required by research ethics board)	√
Patient demographics	√
Patient eligibility	√
Medical history/comorbidities	√
Current ophthalmic diagnosis	√
Duration of macular edema prior to injection	√
Ophthalmic medication history	√
Past ocular treatment history	√
Lens status	√
Ophthalmoscope examination findings	√
Dexamethasone intravitreal implant injection informationd		√
Other medication(s) prior to or concomitantly with injection		√
Other procedures(s) prior to or concomitantly with injection		√
Pre-injection assessmentse		√
Rationale for repeat injection		√
Post-injection assessmentse			√
Post-injection medications			√
Post-injection proceduresf			√
Adverse events		√	√
Prior and concomitant medications	√	√	√
Prior and concomitant procedures	√	√	√
Study completion or early termination			√

Notes:

a Prior to the first injection.

b At the first injection and repeated for each subsequent injection administered.

c Every 4±2 weeks after each injection.

d Injection information: eye(s) treated, date of injection, current retinal disease, rationale for treatment.

e Pre-injection and post-injection assessments: intraocular pressure, best-corrected visual acuity, optical coherence tomography, fluorescein angiography.

f Post-injection procedures: laser photocoagulation, ocular surgery, other ocular procedures.