Retinal Detachment RhegmatogenousPhase 2/3NCT07855770
Use of Preoperative Gas in Eyes With Macula-off Rhegmatogenous Retinal Detachment (RRD)
A Phase 2/3 study testing Intravitreal 100% C3F8 Injection and Pars plana vitrectomy or pars plana vitrectomy with scleral buckle in people with Retinal Detachment Rhegmatogenous, run by Wills Eye at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate whether a preoperative intraocular gas injection improves visual outcomes in patients with a macula-off rhegmatogenous retinal detachment (RRD). While current surgical therapies successfully reattach the retina, visual recovery can vary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment Rhegmatogenous
- What is being tested?
- Intravitreal 100% C3F8 Injection and Pars plana vitrectomy or pars plana vitrectomy with scleral buckle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2026to Mar 2029
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient must meet the following criteria to be eligible for inclusion in the study: 1. Diagnosed with macula-involving primary rhegmatogenous retinal detachment 2. Consents to surgical repair with pars plana vitrectomy with or without scleral buckling 3. Willing and able to comply with clinic visits and study-related procedures
Who cannot join
- A patient who meets any of the following criteria will be excluded from the study: 1. Age < 18 years old 2. Presence of PVR grade C or worse (as defined by the revised Retina Society PVR classification) at time of surgical repair 3. History of or concurrent ruptured globe, intraocular foreign body, proliferative diabetic retinopathy, retinal vein occlusion, exudative age-related macular degeneration, macular epiretinal membrane, sickle cell disease, uveitis or intraocular infectious diseases 4. Not willing or able to comply with clinic visits and study-related procedures 5. Unable to provide a signed informed consent 6. Unable to maintain positioning to support break 7. Patients that undergo silicone oil placement for primary macula-off RRD 8. For bilateral macula-off RRDs, the better seeing eye will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Wilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, 21287
Zainab Rustam, MD, 6674147808, zrustam2@jhmi.edu
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Omar Masoud, MD, 4452133130, omasoud@willseye.org
About this study
Official title: A Prospective, Randomized Study on the Use of Preoperative Gas in Eyes With Macula-off Rhegmatogenous Retinal Detachment (RRD)
The purpose of this study is to evaluate whether a preoperative intraocular gas injection improves visual outcomes in patients with a macula-off rhegmatogenous retinal detachment (RRD). While current surgical therapies successfully reattach the retina, visual recovery can vary. This study will investigate if injecting a small amount of gas (0.3 cc of 100% C3F8) into the eye prior to standard surgery can decrease the duration of macular detachment, reduce retinal displacement, and ultimately result in better final visual acuity compared to the standard of care alone.
Read the detailed description
Macula-off rhegmatogenous retinal detachment (RRD) is associated with compromised visual outcomes. While current standard-of-care therapies (pars plana vitrectomy and scleral buckle) are highly effective at correcting the anatomy, functional visual recovery remains variable. Time to macular reattachment and the extent of retinal reapposition are critical factors influencing ultimate visual acuity.
Small preliminary studies suggest that an intraocular gas injection performed prior to definitive surgical treatment may decrease the duration of macular detachment and minimize retinal displacement, potentially improving visual outcomes. However, there are currently no randomized controlled trials available to validate this approach.
This randomized study aims to determine if a preoperative injection of 0.3 cc of 100% C3F8 gas prior to standard surgical therapy for macula-off RRD results in superior visual acuity compared to the standard of care alone. By evaluating whether preoperative gas injection effectively shortens the duration of macular separation and reduces retinal displacement, this study seeks to demonstrate a clear visual benefit. Positive findings could change clinical management, establishing a new standard of care and significantly improving the visual prognosis for patients presenting with macula-off RRD.
- Conditions
- Retinal Detachment Rhegmatogenous
- Being tested
- Intravitreal 100% C3F8 Injection, Pars plana vitrectomy or pars plana vitrectomy with scleral buckle
- Keywords
- Retinal Detachment, Rhegmatogenous Retinal Detachment, Scleral Buckle, Pars Plana Vitrectomy, C3F8 Gas
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal 100% C3F8 InjectionProcedure or surgery
Patients with Macula off Rhegmatogenous Retinal Detachment will receive an intravitreal injection of 100% C3F8 prior to undergoing surgical repair for their condition
Pars plana vitrectomy or pars plana vitrectomy with scleral buckleProcedure or surgery
Patients with RRD will undergo standard of care treatment of RRD with pars plana vitrectomy or pars plana vitrectomy with scleral buckle
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Gas | Experimental | Patients in this group will be injected with 0.3 cc of 100% C3F8 gas prior to surgical repair of the retinal detachment. Receives: Procedure: Intravitreal 100% C3F8 Injection; Procedure: Pars plana vitrectomy or pars plana vitrectomy with scleral buckle |
| Standard of Care | Active comparator | Patients in this arm will receive standard of care treatment with Pars Plana Vitrectomy or Pars Plana vitrectomy with Scleral Buckle. Receives: Procedure: Pars plana vitrectomy or pars plana vitrectomy with scleral buckle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Best Corrected Visual Acuity
Measured: 6 months
Secondary outcomes (4)
Anatomic Success Rate
Maintenance of retinal attachment and normal retinal structure. Assessed via clinical eye examination, Optical Coherence Tomography Imaging and Fundus autofluorescence.
Measured: 6 months
Ellipsoid Zone disruption
Examination of presence, and extent of, ellipsoid zone disruption via Optical Coherence Tomography.
Measured: 6 months
Retinal Displacement
Assessment of presence, and extent, of retinal displacement via clinical eye examination, Optical Coherence Tomography and Fundus autofluorescence
Measured: 6 months
Metamorphopsia
Assessment of presence, and extent of, metamorphopsia via M-chart examination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start21 Sep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Retinal Detachment RhegmatogenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Ajay Kuriyan, MD, Principal investigator, Wills Eye HospitalSidra Zafar, MD, Principal investigator, The Johns Hopkins Wilmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855770
- Sponsor's protocol ID
- IRB #2025-74
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and confidentiality in accordance with HIPAA regulations and Institutional Review Board (IRB) policies. Only aggregate, de-identified data will be reported in peer-reviewed publications.
Publications
Hwang JC. Regional practice patterns for retinal detachment repair in the United States. Am J Ophthalmol. 2012 Jun;153(6):1125-8. doi: 10.1016/j.ajo.2011.11.034. Epub 2012 Feb 8.
PubMed 22321800Hillier RJ, Felfeli T, Berger AR, Wong DT, Altomare F, Dai D, Giavedoni LR, Kertes PJ, Kohly RP, Muni RH. The Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT). Ophthalmology. 2019 Apr;126(4):531-539. doi: 10.1016/j.ophtha.2018.11.014. Epub 2018 Nov 22.
PubMed 30468761Brosh K, Francisconi CLM, Qian J, Sabatino F, Juncal VR, Hillier RJ, Chaudhary V, Berger AR, Giavedoni LR, Wong DT, Altomare F, Kadhim MR, Newsom RB, Marafon SB, Muni RH. Retinal Displacement Following Pneumatic Retinopexy vs Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment. JAMA Ophthalmol. 2020 Jun 1;138(6):652-659. doi: 10.1001/jamaophthalmol.2020.1046.
PubMed 32324204Felfeli T, Mandelcorn MS, Trussart R, Mandelcorn ED. PREOPERATIVE GAS FOR PARS PLANA VITRECTOMY: A SURGICAL TECHNIQUE FOR REPAIR OF RHEGMATOGENOUS RETINAL DETACHMENTS WITH MULTIPLE, LARGE, OR INFERIOR BREAKS. Retin Cases Brief Rep. 2023 Jul 1;17(4):374-379. doi: 10.1097/ICB.0000000000001197. Epub 2021 Sep 27.
PubMed 34652305