Intravitreal aflibercept injection for Proliferative Vitreoretinopathy

Wills Eye Hospital, Philadelphia, PA
Proliferative Vitreoretinopathy+1 More ConditionsIntravitreal aflibercept injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a medication can help improve the success rate of surgery for people with a certain eye condition.

Eligible Conditions
  • Proliferative Vitreoretinopathy
  • Retinal Detachment With Multiple Breaks, Unspecified Eye

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Treatment Arm
1
Topotecan
1
Netarsudil 0.02%

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 4 months

4 months
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points
OCT-measured central subfield thickness
Single surgery anatomic success (retinal re-attachment) rate
The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging
The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination. Presence of grade C PVR or worse

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Treatment Arm
1
Topotecan
2
Netarsudil 0.02%

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

Intervention (serial IAI)
1 of 2
Control
1 of 2

Experimental Treatment

Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Intravitreal aflibercept injection · Has Placebo Group · Phase 2

Intervention (serial IAI)
Drug
Experimental Group · 1 Intervention: Intravitreal aflibercept injection · Intervention Types: Drug
Control
Other
ShamComparator Group · 1 Intervention: Sham control · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months

Who is running the clinical trial?

Southeastern Retina AssociatesUNKNOWN
University of California, Los AngelesOTHER
1,442 Previous Clinical Trials
10,081,871 Total Patients Enrolled
Eye Associates of New MexicoUNKNOWN
M. Ali Khan, MDLead Sponsor
Mohammed A Khan, MPrincipal InvestigatorWills Eye Hospital

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

To what extent is the participant enrollment for this trial?

"Affirmative. Records hosted on clinicaltrials.gov supply evidence that this research project, first posted on October 15th 2020, is currently seeking participants. Approximately 150 people will be enrolled from a single trial site." - Anonymous Online Contributor

Unverified Answer

What conditions typically respond to Intravitreal aflibercept injection?

"Intravitreal aflibercept injection is both an effective and safe treatment for wet age-related [macular degeneration](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/macular-degeneration) (wAMD). It has also been employed to alleviate associated conditions such as diabetic macular edema, retinal vein occlusion, and choroidal neovascularization." - Anonymous Online Contributor

Unverified Answer

Is it possible to still join this research endeavor?

"According to the data on clinicaltrials.gov, this medical research is actively searching for participants. The trial was published in October 2020 and amended in May 2022." - Anonymous Online Contributor

Unverified Answer

To what extent can intravitreal aflibercept injection pose a risk for patients?

"Our assessment of intravitreal aflibercept injection's safety is rated 2, indicating that while clinical evidence exists to back its security there are no studies attesting to its efficacy." - 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.

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