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Phase 3 N=91 Randomized Treatment

Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration

Neovascular Age Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT00764738 ↗
Enrolled (actual)
91
Serious AEs
2.6%
Results posted
Sep 2020
Primary outcome: Primary: Multifocal Electroretinography N1-P1 Amplitude — 3.6; 5.3; 4.9; 4.0 nV/deg^2

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
OCT, Multifocal ERG, Microperimetry (Device); Ranibizumab Ophthalmic (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Retina Macula Institute
Primary completion
Nov 2011

Outcome Measures

OutcomeResultp-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 —

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.

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
View full record on ClinicalTrials.gov →

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.

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