Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: randomized clinical trial.

Mitchell, Paul; Bressler, Neil; Tolley, Keith; Gallagher, Meghan; Petrillo, Jennifer; Ferreira, Alberto; Wood, Robert; Bandello, Francesco (2013). Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: randomized clinical trial. JAMA ophthalmology, 131(10), pp. 1339-1347. American Medical Association 10.1001/jamaophthalmol.2013.4592

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IMPORTANCE

Few data are available on relative changes in vision-related function after treatment for diabetic macular edema (DME).

OBJECTIVE

To determine the impact of intravitreal ranibizumab, 0.5 mg, compared with laser on patient-reported visual function.

DESIGN

Phase 3, randomized, double-masked, 12-month study (RESTORE).

SETTING

Outpatient retina practices in Australia, Canada, and Europe.

PARTICIPANTS

Patients 18 years or older with type 1 or 2 diabetes mellitus and visual impairment due to DME.

INTERVENTIONS

Patients were randomized to ranibizumab plus sham laser (n = 116), ranibizumab plus laser (n = 118), or sham injections plus laser (n = 111). Ranibizumab and sham injections were given for 3 consecutive months then as needed; laser or sham laser treatment was given at baseline then as needed.

MAIN OUTCOMES AND MEASURES

National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) scores at 0, 3, and 12 months for patients receiving 1 or more study treatments with 1 or more postbaseline NEI VFQ-25 assessments and last observation carried forward for missing data.

RESULTS

Mean baseline NEI VFQ-25 composite scores were 72.8, 73.5, and 74.1 in the ranibizumab, laser, and ranibizumab plus laser groups, respectively. At 12 months, the mean composite scores (95% CIs) improved by 5.0 (ranibizumab vs laser, 2.6 to 7.4; P = .01 vs laser) and 5.4 (ranibizumab plus laser vs laser alone, 3.3 to 7.4; P = .004 vs laser) from baseline in the ranibizumab and ranibizumab plus laser groups, respectively, compared with 0.6 (-1.8 to 3.0) for the laser group. Near activities scores improved by 9.0 (ranibizumab vs laser, 5.0 to 13.0; P = .01) and 9.1 (ranibizumab plus laser vs laser, 5.6 to 12.6; P = .006) compared with 1.1 (-3.0 to 5.2) for the laser group, whereas distance activities scores improved by 5.3 (ranibizumab vs laser, 1.8 to 8.9; P = .04) and 5.6 (ranibizumab plus laser vs laser, 2.3 to 9.0; P = .03) compared with 0.4 (-3.1 to 3.8) for the laser group. Patients with better baseline visual acuity or lower central retinal thickness had greater improvements with ranibizumab treatment compared with laser in composite and some subscale scores compared with patients with worse visual acuity or higher central retinal thickness.

CONCLUSIONS AND RELEVANCE

These data provide vision-related, patient-reported outcome evidence that mirrors visual acuity outcomes and supports benefits from ranibizumab or ranibizumab plus laser treatment for patients with DME and characteristics similar to those enrolled in this randomized clinical trial.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00687804.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ophthalmology
ISSN:	2168-6165
Publisher:	American Medical Association
Language:	English
Submitter:	Christoph Tappeiner
Date Deposited:	18 Apr 2019 15:25
Last Modified:	18 Apr 2019 15:25
Publisher DOI:	10.1001/jamaophthalmol.2013.4592
PubMed ID:	23974915
Additional Information:	C. Tappeiner is a member of "RESTORE Study Group".
URI:	https://boris.unibe.ch/id/eprint/42858