Phase 4
Completed N=99
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)
Source: ClinicalTrials.gov NCT01148511 ↗Enrolled (actual)
99
Serious AEs
10.1%
Results posted
May 2013
Primary outcomePrimary: Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12 — -0.18; -0.12 logMAR
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12 |
-0.18; -0.12 | — |
| PRIMARY Change in Letter Count From Baseline to Month 12 |
-9; -6 | — |
| SECONDARY Letter Count From Baseline to Month 12 |
7.9; 7.7; 92.1; 92.3; 10.5; 10.3 | — |
| SECONDARY Number of Visits |
12.0; 15.0 | — |
| SECONDARY Follow-up Duration |
364.5; 366.0 | — |
| SECONDARY Change in Central Retinal Thickness From Baseline to Month 12 |
88.5; 61.0 | — |
| SECONDARY Quality of Life |
70.0; 73.0; 71.0; 69.5; 69.0; 72.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01148511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.