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Completed

NCT Number: NCT01148511

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)

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.

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Key information

Conditions

Age-Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Adana, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria may apply.

Treatment and study plan

Ranibizumab 0.5 mg

Drug

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

Other names: Lucentis

Primary outcomes

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

    Time frame: 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.

  2. Change in Letter Count From Baseline to Month 12

    Time frame: 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 outcomes

  1. Letter Count From Baseline to Month 12

    Time frame: 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.

  2. Number of Visits

    Time frame: Baseline to Month 12

  3. Follow-up Duration

    Time frame: Baseline to Month 12

    Follow-up duration was defined as the number of days from Baseline to study discontinuation.

  4. Change in Central Retinal Thickness From Baseline to Month 12

    Time frame: Baseline to Month 12

    Retinal thickness was measured using Optical Coherence Tomography (OCT).

  5. Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: SALUTE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 22, 2010
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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