Treatment for Macular Edema

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Department of Ophthalmology, St Michael's Hospital, Toronto, CanadaMacular Edema+3 More
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test the hypothesis that aflibercept intravitreal injections given on a variable dosing regimen is associated with lower aqueous cytokine levels and longer treatment intervals in patients with neovascular age-related macular degeneration, macular edema secondary to retinal vein occlusion and diabetic macular edema.

Eligible Conditions
  • Macular Edema
  • Retinal Vein Occlusion
  • Diabetic Macular Edema
  • Age-Related Macular Degeneration

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: month 2, at the visits closest to injection of months 6, 12 and 18.

18 months
Association between cytokine levels and optimal treatment interval
Average number of injections needed
Cytokine threshold level with visual and anatomic outcomes
Individualized aqueous cytokine curves relationship with treatment response
Month 6
ETDRS visual acuity change
Month 18
Optical coherence tomography change
Snellen BCVA change

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

0 Treatment Group

168 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 2, at the visits closest to injection of months 6, 12 and 18.

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
498 Previous Clinical Trials
375,857 Total Patients Enrolled
7 Trials studying Macular Edema
286 Patients Enrolled for Macular Edema
Rajeev MuniPrincipal InvestigatorUnity Health Toronto
1 Previous Clinical Trials
168 Total Patients Enrolled
1 Trials studying Macular Edema
168 Patients Enrolled for Macular Edema

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

How many subjects are participatng in this experiment?

"Indeed, it appears that recruitment is open for this clinical trial. The details of which were first uploaded on February 28th 2017 and last revised April 27th 2021, calling for 168 participants to be enrolled at two different medical centers." - Anonymous Online Contributor

Unverified Answer

What safety precautions should patients take before undergoing this treatment regimen?

"This treatment has been assessed to be safe and was given a rating of 3. This is because it has obtained approval as an end-stage clinical trial." - Anonymous Online Contributor

Unverified Answer

What type of conditions is this intervention commonly prescribed for?

"Wet age-related [macular degeneration](https://www.withpower.com/clinical-trials/macular-degeneration) (wAMD) is primarily treated with this medication. Additionally, it can be used to ameliorate symptoms of other conditions including Macular edema, Diabetic Macular Edema (DME), and Macular Degeneration." - Anonymous Online Contributor

Unverified Answer

Are there any spots available to join this research endeavor?

"Affirmative. Clinicaltrials.gov details that the clinical trial is currently recruiting, with its initial posting on February 28th 2017 and latest revision occurring April 27th 2021. 168 participants will be accepted from 2 medical centres." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.