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

Primary Purpose

Neovascular Age Related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

OCT, Multifocal ERG, Microperimetry

Ranibizumab Ophthalmic

About this trial

This is an interventional treatment trial for Neovascular Age Related Macular Degeneration focused on measuring ARMD, AMD, exudative AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Retina Macula Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Monthly

As Needed

Arm Description

Ranibizumab injections every month for 12 months.

Ranibizumab injections monthly for 4 months then as needed thereafter.

Outcomes

Primary Outcome Measures

Multifocal Electroretinography N1-P1 Amplitude

As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1).

Microperimetry Mean Sensitivity

Secondary Outcome Measures

Best Corrected Visual Acuity

Central Foveal Thickness on Optical Coherence Tomography

Full Information

NCT ID

NCT00764738

First Posted

September 30, 2008

Last Updated

September 1, 2020

Sponsor

Retina Macula Institute

1. Study Identification

Unique Protocol Identification Number

NCT00764738

Brief Title

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

Official Title

Study Investigating High Resolution OCT, Multifocal ERG and Microperimetry Outcomes of Monthly vs As Needed Ranibizumab in Neovascular Age-Related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Retina Macula Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular Age Related Macular Degeneration

Keywords

ARMD, AMD, exudative AMD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Monthly

Arm Type

Active Comparator

Arm Description

Ranibizumab injections every month for 12 months.

Arm Title

As Needed

Arm Type

Active Comparator

Arm Description

Ranibizumab injections monthly for 4 months then as needed thereafter.

Intervention Type

Device

Intervention Name(s)

OCT, Multifocal ERG, Microperimetry

Intervention Description

OCT performed monthly. Fluorescein Angiography performed at baseline, month 3, month 5, month 8 and month 12. Microperimetry performed at baseline, month 3, month 5, month 8, and month 12 for monthly ranibizumab and at baseline, month 3, month 5 through month 12 for as needed ranibizumab. Multifocal ERG done at the same monthly visits as the microperimetry.

Intervention Type

Drug

Intervention Name(s)

Ranibizumab Ophthalmic

Intervention Description

0.5 mg ranibizumab vs 2.0 mg ranibizumab

Primary Outcome Measure Information:

Title

Multifocal Electroretinography N1-P1 Amplitude

Description

As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1).

Time Frame

One Year

Title

Microperimetry Mean Sensitivity

Time Frame

One Year

Secondary Outcome Measure Information:

Title

Best Corrected Visual Acuity

Time Frame

One Year

Title

Central Foveal Thickness on Optical Coherence Tomography

Time Frame

One Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ron P. Gallemore, MD, PhD

Organizational Affiliation

Retina Macula Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Retina Macula Institute

City

Torrance

State/Province

California

ZIP/Postal Code

90503

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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