Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus Treat and Extend Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)

Comparison of Safety, Effectiveness, and Quality-of-life Outcomes Between Labeled Versus Treat and Extend Regimen in Turkish Patients With Choroidal Neovascularisation Due to AMD

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148511

Acronym

SALUTE

Enrollment

Registered

2010-06-22

Start date

2010-02-28

Completion date

2012-04-30

Last updated

2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

Keywords

Macula degeneration, Ranibizumab, Choroidal neovascularisation, Treat and extend, Treat and observe

Brief summary

The purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual loss of more than 5 letters with monthly control (Treat and Observe). The second treatment regimen was 1 injection each month for 3 months and than extending the control period if the macula is dry during the monthly control (Treat and Extend). If the Treat and Extend regimen is found effective and safe, the number of ranibizumab injections, the number of patient visits, the risk of adverse events due to the intravitreal injections, and policlinic occupation number could all be reduced.

Interventions

DRUGRanibizumab 0.5 mg

Ranibizumab was supplied as a sterile solution in sealed glass vials.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female patients over the age of 50. * Patients with primary, secondary, or recurrent subfoveal choroidal neovascularization (CNV) to AMD with classic, minimal classic, or occult lesions. * Patients with CNV area ≥ %50 of the total lesion. * Total lesion area ≤ 12 disc areas for minimal classic/occult lesions and ≤ 9 disc areas for the classic lesions. * Best-corrected visual acuity (BCVA) score between 73 and 34 letters in the study eye.

Exclusion criteria

* BCVA \< 34 letters. * Patients using anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, corticosteroids, or protein kinase C inhibitors, etc) or inclusion in another trial (for any eye). * Verteporphin, external radiational therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy application to the eye before the study. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12	Baseline to Month 12	Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change in Letter Count From Baseline to Month 12	Baseline to Month 12	Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.

Secondary

Measure	Time frame	Description
Follow-up Duration	Baseline to Month 12	Follow-up duration was defined as the number of days from Baseline to study discontinuation.
Letter Count From Baseline to Month 12	Baseline to Month 12	Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.
Quality of Life	Visits 2, 6, 9, 12, and 15 (up to 12 months)	The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.
Change in Central Retinal Thickness From Baseline to Month 12	Baseline to Month 12	Retinal thickness was measured using Optical Coherence Tomography (OCT).
Number of Visits	Baseline to Month 12	—

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

Arm	Count
Treat and Extend Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.	48
Treat and Observe Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.	45
Total	93

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Exposed to Study Drug	Lost to Follow-up	4	0	0
Exposed to Study Drug	Protocol Violation	2	0	0
Randomized	Adverse Event	0	1	0
Randomized	Consent withdrawal	0	5	3
Randomized	Lost to Follow-up	0	1	1
Randomized	Other	0	1	1
Randomized	Protocol Violation	0	2	1

Baseline characteristics

Characteristic	Treat and Extend	Treat and Observe	Total
Age Continuous	70.8 years STANDARD_DEVIATION 8.8	71.1 years STANDARD_DEVIATION 8.4	70.9 years STANDARD_DEVIATION 8.6
Sex: Female, Male Female	23 Participants	20 Participants	43 Participants
Sex: Female, Male Male	25 Participants	25 Participants	50 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	10 / 48	8 / 45	1 / 6
serious Total, serious adverse events	5 / 48	3 / 45	2 / 6

Outcome results

Primary

Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12

Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

Time frame: Baseline to Month 12