Phase 3
Completed N=91
Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
Source: ClinicalTrials.gov NCT00764738 ↗Enrolled (actual)
91
Serious AEs
2.6%
Results posted
Sep 2020
Primary outcomePrimary: Multifocal Electroretinography N1-P1 Amplitude — 3.6; 5.3; 4.9; 4.0 nV/deg^2
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Multifocal Electroretinography N1-P1 Amplitude |
3.6; 5.3; 4.9; 4.0; 3.4; 4.7 | — |
| PRIMARY Microperimetry Mean Sensitivity |
5.5; 5.1; 5.7; 4.6; 6.7; 7.3 | — |
| SECONDARY Best Corrected Visual Acuity |
48.7; 52.6; 48.6; 54.5; 56.4; 58.6 | — |
| SECONDARY Central Foveal Thickness on Optical Coherence Tomography |
341.2; 298.1; 308.2; 331.1; 246.8; 227.9 | — |
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age greater or equal to 50 years old.
- Patients with active neovascular AMD
Exclusion Criteria
- Pregnancy (Positive pregnancy test) or lactation.
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
- Previous PDT therapy
- Previous intravitreal steroid therapy within last 3 months
- Previous anti-VEGF therapy in the past month
Data sourced from ClinicalTrials.gov (NCT00764738). 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.