Vitreomacular AdhesionRELEASENCT02001701
Intravitreal Gas for Vitreomacular Adhesion
A study testing Intravitreal Injection of sulfahexafluoride gas in people with Vitreomacular Adhesion, run by Northern California Retina Vitreous Associates at 1 site in United States.
Trial summary
Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It is due to an abnormal separation of the vitreous gel from the surface of the retina and macula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreomacular Adhesion
- What is being tested?
- Intravitreal Injection of sulfahexafluoride gas
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18 or older
- Able to provide written informed consent
- Patients with Symptomatic Vitreomacular Adhesion (sVMA) as defined by Clinical and SD-OCT findings:
- Clinical Findings:
- Symptoms: blurred vision, double vision, metamorphopsia, micropsia
- Snellen Visual Acuity: < 20/25 in study eye
Show all 10Show fewer
- SD-OCT (Cirrus, Car Zeiss Meditec, Dublin, CA) Findings:
- Visible vitreous attachment within a 1,500 um radius of the foveal center causing antero-posterior vitreofoveal traction with associated microstructural retinal changes
- See Figure 1 (Image "E") for representative candidates for inclusion.
- Observation period of 1 month prior to intervention allowing for spontaneous resolution
Who cannot join
- Figure 1 (Images "A", "B", "C", "D", "F", "H", "I")
- Any Macular Hole
- Epiretinal Membrane
- History of Diabetic Retinopathy (non-proliferative, proliferative, and/or diabetic macular edema)
- Macular Degeneration
- Retinal vascular occlusion
Show all 15Show fewer
- Aphakia
- High myopia (> -8 diopters)
- Uncontrolled glaucoma
- Vitreous Opacification
- Retinal tear or retinal detachment
- Vitrectomy surgery
- Macular laser
- Figure 1: Refer to the following article:
- Stalmans P, Duker JS, Kaiser PK, et al. OCT-Based Interpretation of the Vitreomacular Interface and Indications for Pharmacologic Vitreolysis. Retina; 2013: Epub ahead of print
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern California Retina Vitreous Associates
Mountain View, California, 94040
About this study
Official title: Intravitreal Injection of Expansile Sulfa Hexafluoride Gas for Symptomatic Vitreomacular Adhesion
Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It is due to an abnormal separation of the vitreous gel from the surface of the retina and macula. The current, gold-standard treatment for this condition involves surgery performed in the operating room that involves risk such as bleeding, infection, cataract, and retinal detachment. It has been previously shown that a less invasive intravitreal injection of a gas bubble performed in the office may also treat vitreomacular adhesion with less risk than surgery.
The purpose of this study is to determine the effect of an office-based injection of an intravitreal gas bubble as a treatment for symptomatic vitreomacular adhesion.
Read the detailed description
Symptomatic vitreomacular adhesion (sVMA), also known as Vitreomacular traction (VMT) is thought to occur due to an anomalous or incomplete posterior vitreous detachment (PVD).1 Typical symptoms of VMT include decreased reading vision and metamorphopsia. Ultra-high resolution spectral-domain optical coherence tomography (SD-OCT) has greatly enhanced our understanding of the spectrum of the vitreomacular interface disorders ranging from focal adhesions, macular cysts, impending macular holes, full thickness macular holes, lamellar holes, and epiretinal membrane.2 Generally, pars plana vitrectomy (PPV) surgery is the preferred treatment for many of these conditions with high success rates.3 However, surgical intervention is not without risk and includes the potential for infection, retinal detachment, cataract progression, and patient discomfort from post-operative prone positioning in cases of macular hole.4 Despite the high success rate with vitrectomy, the risks of surgery have led researchers to search for non-surgical treatments of VMT such as pharmacologic vitreolysis. Ocriplasmin (JetreaTM, ThromboGenics, Inc. Iselin, NJ) was recently approved by the United States Food \& Drug Administration (FDA) in October 2012 as a non-surgical, pharmacologic agent for the treatment of symptomatic VMA.5 Pooled data from two phase III clinical trials of ocriplasmin (MIVI-TRUST)5 demonstrated that approximately 26% of eyes treated with a single intravitreal injection of ocriplasmin (125 ug) compared to 10% of eyes treated with vehicle alone (placebo) resulted in resolution of VMA on OCT at 28 days. Potential side effects of ocriplasmin include transient floaters, zonular instability, and transient vision loss.6 Although the primary outcome of the study achieved a statistically significant result compared to placebo, the less than robust results compared to surgical intervention with the associated high cost of the medication have led retina specialists to question the clinical utility of this medication.
Previous small case series' have demonstrated that an intravitreal gas bubble injection alone (i.e. pneumatic vitreolysis) may lead to macular hole closure through the induction of a PVD.7-9 Additional small cases series' have shown that an intravitreal gas bubble alone may induce a PVD in patients with non-proliferative diabetic retinopathy10 and diabetic macular edema11 in nearly 100% of cases. One small case series showed that an intravitreal gas bubble in combination with an anti-vascular endothelial growth factor agent can cause resolution of VMA in patients with wet macular degeneration in 4/4 (100%) of eyes.12 However, there is a paucity of literature on the specific treatment of isolated VMT with intravitreal gas alone. Recently, Rodriques et al13 demonstrated that a single intravitreal injection of perfluoropropane (C3F8) gas injection may cause VMT resolution in 5/7 (70%) eyes with isolated VMT and in 3/6 (50%) eyes with diabetic macular edema. Although this initial study demonstrated efficacy, the overall success rate of the procedure as well as the visual acuity benefit was limited due to the heterogeneous patient population. Pneumatic vitreolysis may offer a potential safe, low cost, and effective procedure that may pose an alternative to treatment in patients with symptomatic vitreomacular adhesion.
The purpose of the present study is to evaluate the efficacy and safety of the administration of a single intravitreal injection of sulfa hexafluoride (SF6) gas for patients with symptomatic vitreomacular adhesion without concomitant macular hole. Key differences between the present study and that by Rodriques et al.10 are the use of a shorter acting gas bubble (SF6 vs C3F8) and the inclusion of a homogenous patient population with VMA alone.
- Conditions
- Vitreomacular Adhesion
- Being tested
- Intravitreal Injection of sulfahexafluoride gas
- Keywords
- vitreomacular adhesion, vitreomacular traction, macular hole, epiretinal membrane, intravitreal gas, sulfahexafluoride gas, perfluoropropane gas, ocriplasmin, vitrectomy
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Injection of sulfahexafluoride gasProcedure or surgery
After the appropriate sterile and anesthetic preparation of the surgical field, the investigator will administer a single intravitreal injection of 0.3 to 0.5 cc of sulfahexafluoride gas in the study eye. An anterior chamber paracentesis may be performed if necessary. Following the procedure, the optic nerve will be monitored for perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Gas | Experimental | Intravitreal injection of sulfahexafluoride gas Receives: Procedure: Intravitreal Injection of sulfahexafluoride gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with resolution of vitreomacular adhesion at Day 28
Measured: Day 28
Secondary outcomes (6)
Change in Visual Acuity
Measured: Day 14
Change in Visual Acuity
Measured: Day 28
Change in Visual Acuity
Measured: Day 90
Time to resolution of vitreomacular adhesion
Measured: Day 90
Proportion of patients requiring vitrectomy surgery
The investigator may consider vitrectomy surgery if:
- Decrease in Visual Acuity
- Worsening of vitreomacular adhesion on SD-OCT
- Progression of vitreomacular adhesion to macular hole
- No improvement of vitreomacular adhesion by Day 28
Measured: Day 90
Incidence of Retinal Tears and Retinal Detachment
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: No patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Vitreomacular AdhesionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern California Retina Vitreous Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alok S Bansal, MD, Principal investigator, Northern California Retina Vitreous Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001701
- Sponsor's protocol ID
- NCRVA - 2013 - RELEASE
- Acronym
- RELEASE
- Status last verified
- Jan 2016
- First submitted
- 24 Nov 2013
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Stalmans P, Duker JS, Kaiser PK, Heier JS, Dugel PU, Gandorfer A, Sebag J, Haller JA. Oct-based interpretation of the vitreomacular interface and indications for pharmacologic vitreolysis. Retina. 2013 Nov-Dec;33(10):2003-11. doi: 10.1097/IAE.0b013e3182993ef8.
PubMed 23881226Chang LK, Fine HF, Spaide RF, Koizumi H, Grossniklaus HE. Ultrastructural correlation of spectral-domain optical coherence tomographic findings in vitreomacular traction syndrome. Am J Ophthalmol. 2008 Jul;146(1):121-7. doi: 10.1016/j.ajo.2008.03.001. Epub 2008 Apr 25.
PubMed 18439563Witkin AJ, Patron ME, Castro LC, Reichel E, Rogers AH, Baumal CR, Duker JS. Anatomic and visual outcomes of vitrectomy for vitreomacular traction syndrome. Ophthalmic Surg Lasers Imaging. 2010 Jul-Aug;41(4):425-31. doi: 10.3928/15428877-20100525-07. Epub 2010 May 28.
PubMed 20608611Recchia FM, Scott IU, Brown GC, Brown MM, Ho AC, Ip MS. Small-gauge pars plana vitrectomy: a report by the American Academy of Ophthalmology. Ophthalmology. 2010 Sep;117(9):1851-7. doi: 10.1016/j.ophtha.2010.06.014.
PubMed 20816248Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA; MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012 Aug 16;367(7):606-15. doi: 10.1056/NEJMoa1110823.
PubMed 22894573Freund KB, Shah SA, Shah VP. Correlation of transient vision loss with outer retinal disruption following intravitreal ocriplasmin. Eye (Lond). 2013 Jun;27(6):773-4. doi: 10.1038/eye.2013.94. Epub 2013 May 3. No abstract available.
PubMed 23640609Chan CK, Wessels IF, Friedrichsen EJ. Treatment of idiopathic macular holes by induced posterior vitreous detachment. Ophthalmology. 1995 May;102(5):757-67. doi: 10.1016/s0161-6420(95)30958-x.
PubMed 7777275Jorge R, Costa RA, Cardillo JA, Uno F, Bonomo PP, Farah ME. Optical coherence tomography evaluation of idiopathic macular hole treatment by gas-assisted posterior vitreous detachment. Am J Ophthalmol. 2006 Nov;142(5):869-71. doi: 10.1016/j.ajo.2006.05.062.
PubMed 17056375Mori K, Saito S, Gehlbach PL, Yoneya S. Treatment of stage 2 macular hole by intravitreous injection of expansile gas and induction of posterior vitreous detachment. Ophthalmology. 2007 Jan;114(1):127-33. doi: 10.1016/j.ophtha.2006.07.001. Epub 2006 Oct 27.
PubMed 17070585Ochoa-Contreras D, Delsol-Coronado L, Buitrago ME, Velasco-Barona C, Quiroz-Mercado H. Induced posterior vitreous detachment by intravitreal sulfur hexafluoride (SF6) injection in patients with nonproliferative diabetic retinopathy. Acta Ophthalmol Scand. 2000 Dec;78(6):687-8. doi: 10.1034/j.1600-0420.2000.078006687.x.
PubMed 11167234McHugh D, Gupta B, Saeed M. Intravitreal gas injection for the treatment of diabetic macular edema. Clin Ophthalmol. 2011;5:1543-8. doi: 10.2147/OPTH.S25348. Epub 2011 Oct 26.
PubMed 22125399Kim YM, Lee SJ, Koh HJ. Gas-assisted release of vitreomacular adhesion in wet age-related macular degeneration. Retina. 2011 Nov;31(10):2123-4. doi: 10.1097/IAE.0B013E31822F5720. No abstract available.
PubMed 22027799Rodrigues IA, Stangos AN, McHugh DA, Jackson TL. Intravitreal injection of expansile perfluoropropane (c(3)f(8)) for the treatment of vitreomacular traction. Am J Ophthalmol. 2013 Feb;155(2):270-276.e2. doi: 10.1016/j.ajo.2012.08.018. Epub 2012 Nov 17.
PubMed 23164159
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Injection of Expansile Sulfa Hexafluoride Gas for Symptomatic Vitreomacular Adhesion
- ClinicalTrials.gov ID
- NCT02001701
- Acronym / sponsor ID
- RELEASE / NCRVA - 2013 - RELEASE
- Conditions
- Vitreomacular Adhesion
- Keywords
- vitreomacular adhesion, vitreomacular traction, macular hole, epiretinal membrane, intravitreal gas, sulfahexafluoride gas, perfluoropropane gas, ocriplasmin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northern California Retina Vitreous AssociatesUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It is due to an abnormal separation of the vitreous gel from the surface of the retina and macula. The current, gold-standard treatment for this condition involves surgery performed in the operating room that involves risk such as bleeding, infection, cataract, and retinal detachment. It has been previously shown that a less invasive intravitreal injection of a gas bubble performed in the office may also treat vitreomacular adhesion with less risk than surgery.
The purpose of this study is to determine the effect of an office-based injection of an intravitreal gas bubble as a treatment for symptomatic vitreomacular adhesion.
Detailed description
Symptomatic vitreomacular adhesion (sVMA), also known as Vitreomacular traction (VMT) is thought to occur due to an anomalous or incomplete posterior vitreous detachment (PVD).1 Typical symptoms of VMT include decreased reading vision and metamorphopsia. Ultra-high resolution spectral-domain optical coherence tomography (SD-OCT) has greatly enhanced our understanding of the spectrum of the vitreomacular interface disorders ranging from focal adhesions, macular cysts, impending macular holes, full thickness macular holes, lamellar holes, and epiretinal membrane.2 Generally, pars plana vitrectomy (PPV) surgery is the preferred treatment for many of these conditions with high success rates.3 However, surgical intervention is not without risk and includes the potential for infection, retinal detachment, cataract progression, and patient discomfort from post-operative prone positioning in cases of macular hole.4 Despite the high success rate with vitrectomy, the risks of surgery have led researchers to search for non-surgical treatments of VMT such as pharmacologic vitreolysis. Ocriplasmin (JetreaTM, ThromboGenics, Inc. Iselin, NJ) was recently approved by the United States Food \& Drug Administration (FDA) in October 2012 as a non-surgical, pharmacologic agent for the treatment of symptomatic VMA.5 Pooled data from two phase III clinical trials of ocriplasmin (MIVI-TRUST)5 demonstrated that approximately 26% of eyes treated with a single intravitreal injection of ocriplasmin (125 ug) compared to 10% of eyes treated with vehicle alone (placebo) resulted in resolution of VMA on OCT at 28 days. Potential side effects of ocriplasmin include transient floaters, zonular instability, and transient vision loss.6 Although the primary outcome of the study achieved a statistically significant result compared to placebo, the less than robust results compared to surgical intervention with the associated high cost of the medication have led retina specialists to question the clinical utility of this medication.
Previous small case series' have demonstrated that an intravitreal gas bubble injection alone (i.e. pneumatic vitreolysis) may lead to macular hole closure through the induction of a PVD.7-9 Additional small cases series' have shown that an intravitreal gas bubble alone may induce a PVD in patients with non-proliferative diabetic retinopathy10 and diabetic macular edema11 in nearly 100% of cases. One small case series showed that an intravitreal gas bubble in combination with an anti-vascular endothelial growth factor agent can cause resolution of VMA in patients with wet macular degeneration in 4/4 (100%) of eyes.12 However, there is a paucity of literature on the specific treatment of isolated VMT with intravitreal gas alone. Recently, Rodriques et al13 demonstrated that a single intravitreal injection of perfluoropropane (C3F8) gas injection may cause VMT resolution in 5/7 (70%) eyes with isolated VMT and in 3/6 (50%) eyes with diabetic macular edema. Although this initial study demonstrated efficacy, the overall success rate of the procedure as well as the visual acuity benefit was limited due to the heterogeneous patient population. Pneumatic vitreolysis may offer a potential safe, low cost, and effective procedure that may pose an alternative to treatment in patients with symptomatic vitreomacular adhesion.
The purpose of the present study is to evaluate the efficacy and safety of the administration of a single intravitreal injection of sulfa hexafluoride (SF6) gas for patients with symptomatic vitreomacular adhesion without concomitant macular hole. Key differences between the present study and that by Rodriques et al.10 are the use of a shorter acting gas bubble (SF6 vs C3F8) and the inclusion of a homogenous patient population with VMA alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Gas | Experimental | Procedure: Intravitreal Injection of sulfahexafluoride gasIntravitreal injection of sulfahexafluoride gas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 or older
- Able to provide written informed consent
- Patients with Symptomatic Vitreomacular Adhesion (sVMA) as defined by Clinical and SD-OCT findings:
- Clinical Findings:
- SD-OCT (Cirrus, Car Zeiss Meditec, Dublin, CA) Findings:
Key exclusion criteria (15 listed)
- Figure 1 (Images "A", "B", "C", "D", "F", "H", "I")
- Any Macular Hole
- Epiretinal Membrane
- History of Diabetic Retinopathy (non-proliferative, proliferative, and/or diabetic macular edema)
- Macular Degeneration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal Injection of sulfahexafluoride gasAfter the appropriate sterile and anesthetic preparation of the surgical field, the investigator will administer a single intravitreal injection of 0.3 to 0.5 cc of sulfahexafluoride gas in the study eye. An anterior chamber paracentesis may be performed if necessary. Following the procedure, the optic nerve will be monitored for perfusion. | Procedure or surgery | Intravitreal Gas |
Primary outcome
Proportion of patients with resolution of vitreomacular adhesion at Day 28
Time frame: Day 28
6 secondary outcomes
Change in Visual Acuity
Time frame: Day 14
Change in Visual Acuity
Time frame: Day 28
Change in Visual Acuity
Time frame: Day 90
Time to resolution of vitreomacular adhesion
Time frame: Day 90
Proportion of patients requiring vitrectomy surgery
Time frame: Day 90
Incidence of Retinal Tears and Retinal Detachment
Time frame: Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Background: PubMed 23881226Stalmans P, Duker JS, Kaiser PK, Heier JS, Dugel PU, Gandorfer A, Sebag J, Haller JA. Oct-based interpretation of the vitreomacular interface and indications for pharmacologic vitreolysis. Retina. 2013 Nov-Dec;33(10):2003-11. doi: 10.1097/IAE.0b013e3182993ef8.
- Background: PubMed 18439563Chang LK, Fine HF, Spaide RF, Koizumi H, Grossniklaus HE. Ultrastructural correlation of spectral-domain optical coherence tomographic findings in vitreomacular traction syndrome. Am J Ophthalmol. 2008 Jul;146(1):121-7. doi: 10.1016/j.ajo.2008.03.001. Epub 2008 Apr 25.
- Background: PubMed 20608611Witkin AJ, Patron ME, Castro LC, Reichel E, Rogers AH, Baumal CR, Duker JS. Anatomic and visual outcomes of vitrectomy for vitreomacular traction syndrome. Ophthalmic Surg Lasers Imaging. 2010 Jul-Aug;41(4):425-31. doi: 10.3928/15428877-20100525-07. Epub 2010 May 28.
- Background: PubMed 20816248Recchia FM, Scott IU, Brown GC, Brown MM, Ho AC, Ip MS. Small-gauge pars plana vitrectomy: a report by the American Academy of Ophthalmology. Ophthalmology. 2010 Sep;117(9):1851-7. doi: 10.1016/j.ophtha.2010.06.014.
- Background: PubMed 22894573Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA; MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012 Aug 16;367(7):606-15. doi: 10.1056/NEJMoa1110823.
- Background: PubMed 23640609Freund KB, Shah SA, Shah VP. Correlation of transient vision loss with outer retinal disruption following intravitreal ocriplasmin. Eye (Lond). 2013 Jun;27(6):773-4. doi: 10.1038/eye.2013.94. Epub 2013 May 3. No abstract available.
- Background: PubMed 7777275Chan CK, Wessels IF, Friedrichsen EJ. Treatment of idiopathic macular holes by induced posterior vitreous detachment. Ophthalmology. 1995 May;102(5):757-67. doi: 10.1016/s0161-6420(95)30958-x.
- Background: PubMed 17056375Jorge R, Costa RA, Cardillo JA, Uno F, Bonomo PP, Farah ME. Optical coherence tomography evaluation of idiopathic macular hole treatment by gas-assisted posterior vitreous detachment. Am J Ophthalmol. 2006 Nov;142(5):869-71. doi: 10.1016/j.ajo.2006.05.062.
- Background: PubMed 17070585Mori K, Saito S, Gehlbach PL, Yoneya S. Treatment of stage 2 macular hole by intravitreous injection of expansile gas and induction of posterior vitreous detachment. Ophthalmology. 2007 Jan;114(1):127-33. doi: 10.1016/j.ophtha.2006.07.001. Epub 2006 Oct 27.
- Background: PubMed 11167234Ochoa-Contreras D, Delsol-Coronado L, Buitrago ME, Velasco-Barona C, Quiroz-Mercado H. Induced posterior vitreous detachment by intravitreal sulfur hexafluoride (SF6) injection in patients with nonproliferative diabetic retinopathy. Acta Ophthalmol Scand. 2000 Dec;78(6):687-8. doi: 10.1034/j.1600-0420.2000.078006687.x.
- Background: PubMed 22125399McHugh D, Gupta B, Saeed M. Intravitreal gas injection for the treatment of diabetic macular edema. Clin Ophthalmol. 2011;5:1543-8. doi: 10.2147/OPTH.S25348. Epub 2011 Oct 26.
- Background: PubMed 22027799Kim YM, Lee SJ, Koh HJ. Gas-assisted release of vitreomacular adhesion in wet age-related macular degeneration. Retina. 2011 Nov;31(10):2123-4. doi: 10.1097/IAE.0B013E31822F5720. No abstract available.
- Northern California Retina Vitreous AssociatesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alok S Bansal, MD principal investigator
Northern California Retina Vitreous Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal Injection of sulfahexafluoride gas in people with Vitreomacular Adhesion, run by Northern California Retina Vitreous Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with resolution of vitreomacular adhesion at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001701, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.