Phase 3
Completed N=200
A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.
Choroidal Neovascularization Secondary to Pathologic Myopia
Source: ClinicalTrials.gov NCT02034006 ↗
Enrolled (actual)
200
Serious AEs
3.5%
Results posted
Feb 2019
Primary outcomePrimary: Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage — 3; 0; 61; 121 Patients — p=<0.0001
◆ Published Evidence
Emerging
1citation · ~0 / year
OLIMPIC: a 12-month study on the criteria driving retreatment with ranibizumab in patients with visual impairment due to myopic choroidal neovascularization.
Summary
The primary objective of the study was to investigate current criteria driving re-treatment in patients affected by Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM) and experiencing a relapse of the disease after the first administration of ranibizumab.
Linked Publications
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OLIMPIC: a 12-month study on the criteria driving retreatment with ranibizumab in patients with visual impairment due to myopic choroidal neovascularization.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage |
3; 0; 61; 121; 0; 2 | <0.0001 sig |
| PRIMARY Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema |
38; 63; 28; 65; 3; 1 | <0.0001 sig |
| PRIMARY Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts |
41; 79; 27; 50; 1; 0 | <0.0001 sig |
| PRIMARY Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid |
19; 37; 49; 90; 1; 2 | <0.0001 sig |
| PRIMARY Change in Central Subfield Thickness (CSFT) |
-16.15; -34.28; -11.04; -15.83; 1.29; 8.64 | 0.1514 |
| PRIMARY Change in Central Subfield Volume (CSV) |
-0.02; -0.02; -0.00; -0.01; -0.00; 0.01 | 0.1265 |
| PRIMARY Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid |
43; 65; 25; 61; 1; 3 | — |
| PRIMARY Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities |
61; 103; 9; 27; 0; 0 | 0.0103 sig |
| PRIMARY Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters |
37; 69; 14; 28; 38; 70 | 0.0854 |
| PRIMARY Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters |
13; 27; 38; 70; 20; 40 | 0.0114 sig |
| PRIMARY Number of Patients in Different Categories of Changes From Baseline in BCVA |
7; 18; 8; 15; 51; 97 | 0.0049 sig |
| SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye |
7.51; 8.42 | — |
| SECONDARY Mean Number of Ranibizumab Injection |
2.41 | — |
| SECONDARY Time to Re-treatment |
2.56 | — |
| SECONDARY Number of Patients Having Ocular and/or Systemic Adverse Event (AE) |
30; 5; 41; 2 | — |
| SECONDARY Change in Patient Quality of Life From Baseline to Month 2 and Month 12 |
-0.40; -0.15; -0.54; -0.36 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Written informed consent given before any study related procedure is performed
- Diagnosis of active CNV secondary to PM confirmed by complete ocular examination in the affected eye(s) using the following criteria:
- Presence of high myopia greater than -6D of spherical equivalence
- Presence of posterior changes compatible with pathologic myopia (any signs of attenuation of retinal pigment epithelium (RPE) and choroids, mottling of the RPE, tilted disc, geographic atrophy of RPE, Fuchs spots, posterior staphyloma, submacular hemorrhage, lacquer cracks) detected by fundus ophthalmoscopy and fundus photography
- Presence of active leakage from CNV observed through fluorescein angiography (FAG)
- Presence of intra or subretinal fluid demonstrated by Optical Coherence Tomography (OCT)
- BCVA > 24 letters and 150 mmHg or diastolic > 90 mmHg at the time of enrollment
- History of stroke
- Any type of advanced, severe or unstable medical condition or its treatment that could significantly bias the assessment of clinical status and interfere with primary and/or secondary outcome evaluations or put the patient at risk
- Presence of active infectious disease or intra-ocular inflammation in either eye at the time of enrollment
- Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period (including retinal detachment, cataract and pre-retinal membrane of the macula)
- History of pan-retinal or focal/grid laser photocoagulation with involvement of the macular area in the study eye at any time
- History of intraocular treatment with any anti-vascular endothelial growth factor (VEGF), verteporfin photodynamic therapy (vPDT) and any intra-ocular surgery or corticosteroid administration within one month before study entrance
- Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation
- Simultaneous participation in a study that includes administration of any investigational drug
Data sourced from ClinicalTrials.gov (NCT02034006) and the linked publication. 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.