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)

NCT01148511 | Completed Phase 4 Results

• 1 other identifier: CRFB002ATR01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 8

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.

Conditions

Age-related Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to Month 12

• Change in Letter Count From 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.

  Baseline to Month 12

Secondary Outcomes (5)

• Letter Count From Baseline to Month 12

  Baseline to Month 12

• Number of Visits

  Baseline to Month 12

• Follow-up Duration

  Baseline to Month 12

• Change in Central Retinal Thickness From Baseline to Month 12

  Baseline to Month 12

• Quality of Life

  Visits 2, 6, 9, 12, and 15 (up to 12 months)

Study Arms (2)

Treat and Extend

EXPERIMENTAL

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.

Drug: Ranibizumab 0.5 mg

Treat and Observe

ACTIVE COMPARATOR

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.

Drug: Ranibizumab 0.5 mg

Interventions

Ranibizumab 0.5 mg DRUG

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

Also known as: Lucentis

Treat and Extend; Treat and Observe

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• BCVA \< 34 letters.
• Verteporphin, external radiational therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy application to the eye before the study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Adana, Turkey (Türkiye)

Location

Novartis Investigational Site

Ankara, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Turkey (Türkiye)

Location

Novartis Investigative Site

Bursa, Turkey (Türkiye)

Location

Novartis Investigative Site

Eskişehir, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, Turkey (Türkiye)

Location

Novartis Investigative Site

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 22, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 30, 2013
• Results First Posted: May 20, 2013

Record last verified: 2013-05

Locations

TU (8)