NCT03038048

Brief Summary

We are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

January 27, 2017

Last Update Submit

July 21, 2017

Conditions

Age Related Macular DegenerationDiabetic Macular EdemaRetinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • Difference in discomfort between 30g and 33g needle

    Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections

    Day 1

Secondary Outcomes (1)

  • Intraocular pressure 5 minutes post injection

    Day 1

Study Arms (2)

33 g needle - right eye

EXPERIMENTAL

33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye

Procedure: Varying needle size with intravitreal ranibizumab or aflibercept

33 g needle - left eye

EXPERIMENTAL

33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye

Procedure: Varying needle size with intravitreal ranibizumab or aflibercept

Interventions

Varying needle size with intravitreal ranibizumab or afliberceptPROCEDURE

Varying gauge of needle, 33 gauge vs 30 gauge

Also known as: Lucentis, Eylea
33 g needle - left eye33 g needle - right eye

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab oraflibercept for the diagnosis of wet AMD, DME, or RVO-associated macular edema

You may not qualify if:

  • \) Patients who do not receive Betadine ophthalmic solution prior to intravitreal injection due to documented allergy 2) Patients who are receiving intravitreal bevacizumab (this medication iscompounded into pre-filled 1-mL tuberculin syringes).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid Atlantic Retina- Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Macular DegenerationRetinal Vein Occlusion

Interventions

afliberceptRanibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Allen Chiang, MD

    Mid Atlantic Retina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Allen Chiang, MD

Study Record Dates

First Submitted

January 27, 2017

First Posted

January 31, 2017

Study Start

January 27, 2017

Primary Completion

April 27, 2017

Study Completion

April 27, 2017

Last Updated

July 25, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)